MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-19 for UNKNOWN NEUROSTIMULATOR 37604 manufactured by Medtronic Puerto Rico Operations Co..
[62699719]
(b)(6). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[62699720]
Information was received from a health care provider (hcp) of a clinical study regarding a patient who was implanted with a neurostimulator for obsessive compulsive disorder (ocd). It was reported that the patient was diagnosed with an infection and was hospitalized as a result of having the device implanted. The patient presented to the emergency department on (b)(6) 2016 for increased swelling and pain surrounding the right implantable neurostimulator (ins) pocket following the implant procedure on (b)(6) 2016. The patient was transferred to a infectious diseases specialist and a blood test was performed. The blood test resulted in a raised c-reactive protein (crf) of 105 and normal white cell count (wcc). The patient was treated with iv of flucloxacillin and was discharged on (b)(6) 2016; mild erythema swelling around the battery site was noted. A follow-up visit was planned to reassess the infection and the patient's oral antibiotics on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[73277925]
Patient Sequence No: 1, Text Type: N, H10
[73277926]
Additional information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep). It was reported that the patient was discharged on (b)(6) 2017. It was also noted that the serious adverse event (sae) was resolved without sequelae on (b)(6) 2017; however, the right upper chest swelling remains ongoing.
Patient Sequence No: 1, Text Type: D, B5
[74186950]
Information references the main component of the system, other applicable components are: product id 3389-40, lot# 0211637645, product type: lead. Product id: 3389-40, lot# 0211433098, product type lead.
Patient Sequence No: 1, Text Type: N, H10
[74186951]
Information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator. It was reported that the patient experienced pain post-deep brain stimulation (dbs) surgery and swelling of the right breast so they were referred to a physiotherapist for pain management. Performing an ultrasound on the patient's breast where the implantable neurostimulator (ins) was located was discussed. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[78085232]
The additional information received revealed that this event is a duplicate of the event reported under report number 3004209178-201 7-13314. To this end, all additional information received will be submitted under report number 3004209178-2017-13314 rather than this report. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[78085233]
The additional information received revealed that this event is a duplicate of the event reported under report number 3004209178-201 7-13314. To this end, all additional information received will be submitted under report number 3004209178-2017-13314 rather than this report.
Patient Sequence No: 1, Text Type: D, B5
[83753474]
Information references the main component of the system, other applicable components are: product id 3389-40 lot# 0211637645, explanted: (b)(6) 2017, product type lead product id 3389-40 lot# 0211433098, explanted: (b)(6) 2017, product type lead.
Patient Sequence No: 1, Text Type: N, H10
[83753475]
Additional information was receive from a health care provider (hcp) of a clinical study via a manufacturer representative (rep). It was reported that the patient was participating in an obsessive compulsive disorder (ocd) study and due to an infection, the implantable neurostimulator (ins) will be explanted on (b)(6) 2017; there are plans to replace the device. It was also noted that an infection (abscess) occurred over the patient's scalp leads and the health care provider (hcp) thought it was almost certainly related to their initial ins infection. The hcp also noted that based on the natural history, there will be an eventual breakdown of the thinned skin blister at the infection site, and the only active treatment option is removal of the deep brain stimulation (dbs) system; the patient was also previously treated with iv antibiotics. It was confirmed that the patient will continue treatment as there was some benefit to their ocd. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2016-04454 |
| MDR Report Key | 6185040 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-19 |
| Date of Report | 2017-06-21 |
| Date of Event | 2016-11-13 |
| Date Mfgr Received | 2017-06-09 |
| Device Manufacturer Date | 2015-08-26 |
| Date Added to Maude | 2016-12-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS,PR MN 007771200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 007771200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN NEUROSTIMULATOR |
| Product Code | MFR |
| Date Received | 2016-12-19 |
| Model Number | 37604 |
| Catalog Number | 37604 |
| Device Expiration Date | 2017-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS,PR MN 007771200 US 007771200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-12-19 |