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 2020-02-21 for ACTIVA 37612 manufactured by Medtronic Med Rel Medtronic Puerto Rico.
[182636396]
Updated to serious injury per additional information received. Estimated event date based on event information. Month and year are accurate. Activa rc 37612 is not approved for dystonia in the us. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182636397]
Additional information was received. It was reported the patient underwent bowel surgery on (b)(6) 2020 with electrocautery using radio frequency energy. The patient was transported to the hospital in the evening due to worsened dystonia during the day. The physician found the ins off when they interrogated it, but the ins was charged to 100% and the patient recharges almost every day. The ins was turned on and the patient began to feel benefit of therapy again. All programs and settings were there and correct with stimulation at 5. 5 v bilaterally. The physician started the patient at a lower amplitude of 3. 5 v bilaterally and gave the patient the possibility to adjust amplitude during the night. It was noted the patient was not feeling anything strange in their body. There was no longer a por displayed when checking the programmer or recharger, and the patient was able to adjust amplitude without problems. It was noted the physician did not want to increase amplitude because of the "happening" the prior days and they did not wish to provoke a dystonic crisis. Additional information indicated the por was a parity por, and it was believed to have been the result of the (unrelated) bowel surgery.
Patient Sequence No: 1, Text Type: D, B5
[186820175]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186820176]
It was reported there was a power on reset displaying on the insr (recharger). The stimulation efficacy is not the same as last week, but the patient was recharging the ins as usual. The patient could not find the patient programmer, so the por was not confirmed on there. Additionally, the patient could not tell if any energy was lacking on the recharger display.
Patient Sequence No: 1, Text Type: D, B5
[188903704]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188903705]
Additional information confirmed that the patient experienced dystonic crisis as a result of the event. It was also confirmed that the ins was not turned off prior to the bowel surgery because the patient had forgotten their programmer. The event was resolved at the time of this supplemental report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2020-00338 |
| MDR Report Key | 9739537 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2010-01-15 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 MED REL MEDTRONIC PUERTO RICO |
| 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 | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) |
| Product Code | MRU |
| Date Received | 2020-02-21 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Device Expiration Date | 2010-12-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-21 |