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 2016-12-22 for UNKNOWN DEEP BRAIN NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[63108926]
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
[63108927]
A healthcare professional (hcp) for a clinical study reported via a representative that there was a diagnosis of device infection which required hospitalization. The patient presented and was admitted to the hospital on (b)(6) 2016 for increased swelling and pain surrounding implanted right chest battery device following surgery insertion on (b)(6) 2016. Blood tests showed raised crf (corticotrophin-releasing hormone) of 105 and normal white cell count; intravenous (iv) flucloxacillin was commenced on (b)(6) 2016. The patient was transferred and admitted to another hospital on (b)(6) 2016 and was assessed by hcps for further treatment and infection control advice, including blood tests and iv antibiotics. Device site infection was diagnosed on (b)(6) 2016 with some mild erythema and swelling around the battery site. On (b)(6) 2016, the patient was discharged. Follow-up appointments with the hcps occurred on (b)(6) 2016. The iv antibiotics, which were administered from (b)(6) 2016 until discharge, settled the erythema and swelling. The patient remained on oral antibiotics since discharge and had a follow-up appointment scheduled for (b)(6) 2016. The outcome was described as? Continuing? But the event did not require device removal. Relationship to device was? Probable.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2016-04516 |
| MDR Report Key | 6198907 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-11-13 |
| Date Mfgr Received | 2016-11-28 |
| Date Added to Maude | 2016-12-22 |
| 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 | DIANE WOLF |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263987 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEEP BRAIN NEUROSTIMULATOR |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MFR |
| Date Received | 2016-12-22 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-12-22 |