MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-03-06 for ACTIVA 37612 manufactured by Medtronic Neuromodulation.
[138302339]
Initial reporter was from the us. The patient was in (b)(6) when the issue occurred. Epilepsy is not an approved indication for the activa rc (model 37612); therefore, this is an off-label use of this device. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[138302340]
Information was received from a friend or family member of a patient with an implantable neurostimulator (ins) for dystonia. It was reported that the patient was unable to charge their ins, and they were having trouble charging the recharger as well. The recharger screen was not coming on, but they were not sure what was causing the ins recharger to not charge the ins. The caller was unsure if the recharger cable was pinched during travel or what happened, but there was not physical damage was confirmed. The issue began to occur within the last two weeks. The patient has a second recharger which is giving them intermittent issues. The patient's recharger will be replaced. There caller also stated that the patient was difficult to understand, and they did not know if it was due to dystonia progression or a side effect of ins therapy. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-00550 |
| MDR Report Key | 8394877 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-03-06 |
| Date of Report | 2019-03-06 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-03-06 |
| 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 | ACTIVA |
| Generic Name | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) |
| Product Code | MRU |
| Date Received | 2019-03-06 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| 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 | 2019-03-06 |