MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-12-12 for ACTIVA 37601 manufactured by Medtronic Med Rel Medtronic Puerto Rico.
[62377952]
The main component of the system and other applicable components are: product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator.
Patient Sequence No: 1, Text Type: N, H10
[62377953]
The mother of the patient reported that the patient had symptom worsening and intermittent relief that occurs daily. Turning the implant off at night has been attempted to resolve the issue which helps for a bit, and the patient has had no falls/trauma or emi related. It was stated that the patient cannot function 99% of the time because stimulation is causing their depression to worsen, and they cannot get out of bed a lot of time, interact with family, think straight, or work. The issues have been going on for the past year prior to date notified and turning stimulation off helps but then all of the sudden the symptoms come back and they have to turn stimulation back on. The patient's depression has begun to manifest into physical symptoms like back pain and physical body pain, with their depression continually deteriorating. The patient's indication for implant is obsessive compulsive disorder and movement disorders.
Patient Sequence No: 1, Text Type: D, B5
[102104222]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2016-26248 |
| MDR Report Key | 6167235 |
| Report Source | CONSUMER |
| Date Received | 2016-12-12 |
| Date of Report | 2016-12-12 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2016-11-16 |
| Device Manufacturer Date | 2013-10-07 |
| Date Added to Maude | 2016-12-12 |
| 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 MED REL MEDTRONIC PUERTO RICO |
| Manufacturer Street | CEIBA NORTE INDUSTRIAL PARK, R |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| 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 | MFR |
| Date Received | 2016-12-12 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| Device Expiration Date | 2015-03-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
| Manufacturer Address | CEIBA NORTE INDUSTRIAL PARK, R JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-12 |