MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-06-05 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[76637847]
Concomitant products: product id 7426, lot# serial#: unknown product type: implantable neurostimulator. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[76637848]
Information was received from a family member regarding a patient who was implanted with a neurostimulator for obsessive compulsive disorder (ocd). It was reported that the patient was implanted with deep brain stimulation (dbs) on (b)(6) 2013 and one of the electrodes was explanted in (b)(6) 2017 due to an infection. It was also noted that there was not a greater than (b)(4) reduction in symptoms. The cause and what troubleshooting was performed related to the event were unknown. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[91843422]
Concomitant products: product id 7426, lot# serial#: unknown product type: implantable neurostimulator. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100965383]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-02154 |
| MDR Report Key | 6610590 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-06-05 |
| Date of Report | 2017-06-21 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-06-15 |
| Date Added to Maude | 2017-06-05 |
| 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 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 IMPLANTABLE NEUROSTIMULATOR |
| Product Code | MFR |
| Date Received | 2017-06-05 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2017-06-05 |