ACTIVA
Report
- Report Number
- 3004209178-2014-17138
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Report Date
- August 27, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V875361, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V741339, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT AND THE PATIENT WAS HAVING A RETURN OF SYMPTOMS. THE PATIENT WAS SHAKING VERY BADLY. THE PATIENT HAD STARTED SHAKING ON THE DATE OF THIS REPORT AND THE SYMPTOMS HAD COME ON SUDDENLY. THE PATIENT FELT LIKE THE STIMULATOR WAS TURNED ON. THEY HAD TRIED TO USE THE PROGRAMMER BUT HAD ENCOUNTERED POOR COMMUNICATION HOWEVER THIS WAS RESOLVED WITH REPOSITIONING OF THE ANTENNA. IT WAS CONFIRMED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON AND THE PATIENT HAD TRIED TO INCREASE BUT HAD ENCOUNTERED THE UPPER LIMIT SCREEN ON BOTH SIDES WHEN TRYING TO INCREASE. NO INTERVENTIONS OR OUTCOME WERE PROVIDED REGARDING THE EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571551 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR |