ACTIVA
Report
- Report Number
- 3004209178-2017-24509
- Event Type
- Injury
- Date Received
- November 29, 2017
- Date of Event
- November 20, 2017
- Report Date
- December 14, 2017
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00613994934611
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
INFORMATION PREVIOUSLY REPORTED IN MANUFACTURER'S REPORT # 230617155 REGARDING THIS PATIENT WAS INCORRECT RELATING TO THIS INS. THIS INFORMATION IS BEING CAPTURED IN MANUFACTURER'S REPORT # 230618628. DISREGARD PREVIOUS INFORMATION REPORTED IN MANUFACTURER'S REPORT # 230617155. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT#: V821660. IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD, PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE WIRES CAME DISCONNECTED SO THEY HAD TO FIX THAT. NO FURTHER INFORMATION WAS KNOWN.
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL AND MOVEMENT DISORDERS. THE PATIENT HAD A REVISION. THE INS WAS REPLACED ON (B)(6) 2017 BECAUSE THE PATIENT HAD NEW LEADS REPOSITIONED. NO MEDICAL SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847870 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37612 | 00613994934611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |