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..
[185088401]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185088402]
Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that the patient's ins uncharges really fast. The patient explained that she would charge her device at night and the next day, it would drop to half charge and she starts having tremors. Patient services explained that therapy would stop if the ins was too low or depleted. The patient stated that when the ins is, she does not have tremors. The patient noticed her tremors coming back due to the ins depleting so quickly. She also felt weird in her head and thought her tremors may be getting worse, so she "upped her numbers. " the patient changed her settings, then turned it down because it "felt kinda weird. " the patient said she does not feel comfortable changing her own settings and would rather have her hcp make adjustments. The patient was advised to contact her hcp to discuss ins depleting quickly and her symptoms. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[188687115]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188687116]
Additional information received from the consumer reported the circumstances that led to the ins depleting quickly and symptoms was it made the consumer? Feel funny in my head and it would turn off and i would have to reset the setting.? The issue was not resolved as it was? Taking forever to charge and it depletes quickly.? The consumer was waiting to see their neurologist as they weren? T sure if their voltage was right. No further complications were anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06203 |
| MDR Report Key | 9884760 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2018-08-27 |
| 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 | 2019-07-14 |
| 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 |