MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for ACTIVA 37601 manufactured by Medtronic Puerto Rico Operations Co..
[186722364]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186722365]
It was reported that the patient had their ins removed due to fever, and redness at the battery site, which was also warm to the touch. The surgery was on march 26th to remove the battery and extensions. The account thought they would have the device analyzed but given the current climate (covid 19) they are wondering what to do, so the hospital still has the device. The issue was said to be resolved at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[187192800]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187192801]
Additional information received from the manufacturer? S representative (rep), which was confirmed with the healthcare provider (hcp), reported the consumer had a confirmed infection prior to explant, but the rep. Had no further information related to the event. The rep. Presumed the hospital was going to keep the explanted device. No further complications were anticipated.
Patient Sequence No: 1, Text Type: D, B5
[187328612]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187328613]
Additional information was received from the manufacturer representative (rep) stating that the device was in pathology and did not know if it will be returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06363 |
| MDR Report Key | 9897512 |
| Report Source | HEALTH PROFESSIONAL |
| 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 | 2018-12-04 |
| 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 | 37601 |
| Catalog Number | 37601 |
| 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 | 1. Required No Informationntervention | 2020-03-30 |