FDA Adverse Event
Malfunction
Summary report: N
ACTIVA RC
MDR report key: 1950365
·
Received December 14, 2010
Report
- Report Number
- 3004209178-2010-10463
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 23, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFO, THE PT AND PHYSICIAN FELT THERE WAS A LOSS OF THERAPEUTIC STIMULATION ONCE THE BATTERY WAS AT 50-75%. DEVICE WAS IMPLANTED OVER 6 MONTHS AGO AND THE PT HAS HIGH SETTINGS IN TERMS OF AMPLITUDE AND PULSE WIDTH. PT CURRENTLY HAS TO RECHARGE EVERY DAY DUE TO THE FEELING OF LOOSING STIMULATION. IMPEDANCES READINGS ARE OKAY. PT OUT COME IS REPORTED AS NO INJURY. IF ADD'L INFO BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA RC | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37612 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |