MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-30 for ACTIVA 37612 manufactured by Medtronic Puerto Rico Operations Co..
[185543580]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185543581]
It was reported that the patient is concerned because their rechargeable implantable neurostimulator (ins) has shown that it has been at 100% for 36 hours. The patient clarified that their ins battery is not depleting and they cannot charge their ins due to this. They mentioned their ins was located in their belly. There are no return of symptoms reported. The manufacturer representative (rep) walked the patient through using the patient programmer (pp) and the pp batteries showed 50% and the ins showed 100%. They stated that the patient mentioned that the pp screen was flashing off and then said it was on. Thus, it is unknown whether the therapy had been off or not and for how long. The patient's recharger, when attempting to charge showed 100% and no bars. Technical services reviewed that since the therapy is confirmed on now, to wait and see if the battery depletes, if not, for the rep to call back. The patient called and confirmed on the call that stimulation was on and their pp was showing 100%. They stated they were able to successfully charge their ins briefly and then described seeing either the charge sufficient or charge complete screen on their implantable neurostimulator recharger (insr), but could not clarify which screen they were seeing. The patient stated that stimulation may have been turned off before. Patient services recommended the patient to monitor their ins battery level now that it is confirmed stimulation is on and call back if the issue persists.
Patient Sequence No: 1, Text Type: D, B5
[186460447]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186460448]
Additional information was received that the patient believes the reason it was not depleting was due to their having accidentally turning their device off. They stated they believed they turned it off while checking the charge with their patient programmer (pp). This resulted in the battery not depleting. The patient turned their device back on and was allowing "a couple of days" to go by before charging. They stated the issue was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06374 |
| MDR Report Key | 9897860 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-30 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-26 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-08-16 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-30 |