FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 4243527
·
Received November 11, 2014
Report
- Report Number
- 3004209178-2014-21320
- Event Type
- Malfunction
- Date Received
- November 11, 2014
- Date of Event
- October 19, 2014
- Report Date
- October 20, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT FELT SUDDEN PALPITATION SYMPTOMS AND THEIR WHOLE BODY FELT RIGID FOLLOWING A PARAMETER ADJUSTMENT ON (B)(6) 2014. THE PATIENT¿S SYMPTOMS GOT BETTER AFTER THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF. WHEN THE INS WAS TURNED ON THE FOLLOWING DAY, THE SYMPTOMS REAPPEARED. AT THE TIME OF THIS REPORT THE INS WAS TURNED OFF. THE PATIENT HAD AN APPOINTMENT TO BE REPROGRAMMED ON (B)(6) 2014. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726838 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR |