MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for ACTIVA 37601 manufactured by Medtronic Puerto Rico Operations Co..
[185751703]
Date of the event (b)(6) 2020 is an estimate. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185751704]
It was reported that about 2 days ago and confirmed "this week," the patient tried to connect to the implantable neurostimulator (ins) and got an out of regulation (oor) on the patient programmer (pp). They were able to bypass the oor once they replaced the batteries in the pp. They have not changed the batteries since they were implanted. Batteries were reviewed. It was also reviewed that heavy duty batteries is not recommended. The patient was redirected to follow up with their healthcare provider (hcp) regarding having the therapy checked. No patient symptoms were reported. Additional information was received from the patient stating that they were still seeing oor on the patient programmer (pp) when patient went to check their settings. It was reviewed for the patient that oor is out of regulation and that the electrical demand on the device is greater than what it was able to deliver. Patient was redirected to the health care provider (hcp) to determine the reason for the oor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06451 |
| MDR Report Key | 9903487 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2017-03-07 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| Device Expiration Date | 2018-08-28 |
| 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 | 2020-03-31 |