MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-26 for ACTIVA 37612 manufactured by Medtronic Puerto Rico Operations Co..
[185093313]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185093314]
The patient services specialist (pss) wanted to ensure everything was working with patient's therapy per patient's initial statement of "it" not working. Patient connected the recharger to the implantable neurostimulator (ins) and was able to obtain full coupling. It was confirmed ins was on. Patient noted that their parkinson's had progressed a lot without making any allegations about the device. During the call, patient lost coupling and had a hard time regaining coupling boxes, was able to get back up to 6. Patient also noted that their ins does move around inside the body. Patient also mentioned that she fell, and fell right on top of it. Patient noted that she had fallen so many times she doesn't know, but this issue/fall was probably about a year or 2 ago. Patient also stated that stress makes her dyskinesia kick in, so patient is probably moving the recharger antenna more than they should be. Patient did not allege that this was related to the device or therapy. Patient was redirected to the health care provider (hcp) to discuss the ins moving around and to help with charging in person.
Patient Sequence No: 1, Text Type: D, B5
[188943243]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188943244]
Additional information was received stating the falls did not affect the device/therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06198 |
| MDR Report Key | 9884493 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2015-12-28 |
| Date Added to Maude | 2020-03-26 |
| 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 PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| 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 | MHY |
| Date Received | 2020-03-26 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Device Expiration Date | 2016-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |