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 2018-05-22 for ACTIVA 37612 manufactured by Medtronic Puerto Rico Operations Co..
[108893949]
Pma: dystonia is an off-label indication for activa rc (model no: 37612). Country event occurred in was the (b)(6). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[108893950]
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia. It was reported the ins depletes quickly. The patient charged the ins to 100% on (b)(6) 2018 and six days later, the ins was "low" per the programmer. Ins recharging data indicated the ins was 93% at 4. 0 v and 25% at 3. 715 v on those dates, respectively. Impedances were measured several times including during palpation over parts of the implant. No abnormalities were found, other than an impedance of 2200 ohms on pair c/3 when measured below 3. 0 v which resolved after re-measuring the impedances at 3. 0 v. Impedances from a month prior to the notify date were also normal. The patient was programmed on c+1- at 5. 5 v, 130 hz, 120 microsecond pw on left side (therapy impedance: 1080 ohms) and c+9- at 5. 0 v, 130 hz, 120 microsecond pw on right side (therapy impedance: 1020 ohms). The patient had the ability to adjust the amplitude between 3. 5 and 5. 9 v on the left side and 3. 0 and 5. 4 v on the right side. A recharge duration calculation estimated the ins would deplete from 100% to 25% in 8. 1 days and to 0% in 10. 9 days. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[114063263]
Product event summary: information received by medtronic indicated that the ins was depleting quickly. There were no symptoms associated with the depletion. Preliminary geo assessment: ins implant date: unknown - ins depleted from 93% to 25% in 6 days; recharger duration estimate was 8 days for 100% to 25%. Depletion interval corresponds approximately to estimated recharge interval, per tech services - no out of range impedances including while palpating device - no other device abnormalities noted - impedances were similar in (b)(6) 2018 and (b)(6) 2018 - no interventions have been taken - unknown if issue has resolved - system checked and no anomalies found - event thought to be related to the rounding of percentages leading to perceived lower charge by patient despite correct device functioning preliminary geo conclusion: ins may be depleting quickly. Suspect device contributed to event. No serious deterioration in health has occurred. (dought2, (b)(6) 2018). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[114063264]
Additional information clarified that on (b)(6) 2018, the recharger showed a lower charge percentage than what the patient was used to seeing during their typical 2 times per week recharging routine. The system had been fully checked and there were no anomalies found, and the cause was not determined. It was thought that the issue was probably related to the rounding of percentages on the recharger, leading to perceived lower charged by patient despite correct functioning of the device. No actions have been taken related to the event. No further complications are anticipated.
Patient Sequence No: 1, Text Type: D, B5
[126688206]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[126688207]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2018-11481 |
| MDR Report Key | 7533103 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-22 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2016-03-21 |
| Date Added to Maude | 2018-05-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2018-05-22 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Device Expiration Date | 2017-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| 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 |
| Brand Name | ACTIVA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MBX |
| Date Received | 2018-05-22 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Device Expiration Date | 2017-02-14 |
| 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 | 2018-05-22 |