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 37601 manufactured by Medtronic Puerto Rico Operations Co..
[185115449]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185115450]
It was reported they were seeing a flashing triangle with an exclamation point on their patient programmer (pp) today. Then a week or so ago, they were seeing off and only noticed because they were feeling real bad and had no motor skills. They do not know how the implantable neurostimulator (ins) was off. They stated they are seeing 2. 77v on the pp for their ins. Patient services reviewed button use, elective replacement indicator (eri) and end of service (eos) voltage. Troubleshooting resolved the issue.
Patient Sequence No: 1, Text Type: D, B5
[188155121]
Product id neu_ptm_prog, serial# unknown. Product type programmer, patient. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188155122]
Additional information was received that the cause of the triangle was probably operator error. The cause of the ins being off was not known. The symptoms went away when the ins was turned on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06208 |
| MDR Report Key | 9885063 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2015-12-21 |
| 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 | 37601 |
| Catalog Number | 37601 |
| Device Expiration Date | 2017-06-14 |
| 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 |