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 2018-10-03 for ACTIVA 37601 manufactured by Medtronic Neuromodulation.
[122481362]
Other relevant device(s) are: product id: 37085-40, serial/lot #: (b)(4), ubd: 05-may-2015, udi#: (b)(4); product id: 37085-40, serial/lot #: (b)(4), ubd: 05-may-2015, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[122481363]
Information was received from a healthcare provider about a patient with an implantable neurostimulator (ins) for epilepsy. It was reported that the patient's ins was being replaced as it was near end of life. There were no issues with the ins noted. During the procedure, the patient's extensions were damaged. The extensions were explanted and replaced during the same procedure and the issue was resolved. There were no symptoms reported. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[123704398]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[123704399]
Additional information noted the hcp of the clinical study did not consider it a device deficiency as the extensions were damaged during the replacement procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-02930 |
| MDR Report Key | 7929720 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-03 |
| Date of Report | 2018-10-12 |
| Date of Event | 2015-12-09 |
| Date Mfgr Received | 2018-10-04 |
| Date Added to Maude | 2018-10-03 |
| 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 | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MBX |
| Date Received | 2018-10-03 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| 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 | 2018-10-03 |