MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-27 for ACTIVA 37603 manufactured by Medtronic Puerto Rico Operations Co..
[186751547]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186751548]
It was reported that an issue with therapy began when the healthcare provider (hcp) had the patient attempt to use different groups and increase amplitude. They tried using groups a, b, and c. It was stated "group c was the best for therapy, b wasn't providing the best relief. " they were turning the amplitude up as high as 4. 3v on group b, causing the patient to experience tightness on the shoulder and brow initially when stimulation was turned up. With high amplitudes, the patient was experiencing "a little bit of hallucinations at night" so the hcp recommended they turn the amplitude down at night and they have been turning down to 2. 5v, which has "reduced nightmares. " no troubleshooting was requested. Additional information was received that the patient was experiencing both hallucinations and nightmares. They were unsure if the ha llucinations were causing the nightmares. When asked if programming was able to be changed and whether symptoms resolved, it was stated the patient reduces the amplitude at night and is seeing "some reduction" in nightmares and they are still working with the hcp to monitor further.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06297 |
| MDR Report Key | 9891684 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2018-01-09 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | 37603 |
| Catalog Number | 37603 |
| Device Expiration Date | 2019-06-28 |
| 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 | 2020-03-27 |