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 2018-05-22 for ACTIVA 37612 manufactured by Medtronic Puerto Rico Operations Co..
[109377523]
Dystonia is an off-label indication for activa rc (model no: 37612). Country event occurred in was the (b)(6). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[109377524]
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia. The patient felt weird sensation during certain movements. It was further clarified that the patient feels a tingle throughout the body like when using a vacuum cleaner. Impedances were measured several times including during palpation over parts of the implant. No abnormalities were found, other than an impedance of 2200 ohms on pair c/3 when measured below 3. 0 v which resolved after re-measuring the impedances at 3. 0 v. Impedances from a month prior to the notify date were also normal. The patient was programmed on c+1- at 5. 5 v, 130 hz, 120 microsecond pw on left side (therapy impedance: 1080 ohms) and c+9- at 5. 0 v, 130 hz, 120 microsecond pw on right side (therapy impedance: 1020 ohms). No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[113822923]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[113822924]
Additional information clarified the tingling/shocking sensation only occurred one time so far while using the vacuum in (b)(6) 2018. The root cause was not determined, but no actions had been taken to resolve the event. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[130375141]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2018-11480 |
| MDR Report Key | 7533105 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-22 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2016-03-21 |
| Date Added to Maude | 2018-05-22 |
| 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 | 2018-05-22 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Device Expiration Date | 2017-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| 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 |
| Brand Name | ACTIVA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MBX |
| Date Received | 2018-05-22 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Device Expiration Date | 2017-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC 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 | 2018-05-22 |