FDA Adverse Event
Injury
Summary report: N
ACTIVA PC
MDR report key: 1901960
·
Received November 12, 2010
Report
- Report Number
- 3007566237-2010-09403
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 28, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE NEURO STIMULATOR (INS) EXHIBITED AN EOS (END OF SERVICE) MESSAGE AFTER 3 MONTHS. BATTERY VOLTAGE ON (B)(6) 2010, WAS 2.63 VOLTS, BUT 3 DAYS LATER, BATTERY VOLTAGE WAS 2.84 VOLTS. ALSO SKIN EROSION WAS REPORTED AT THE CORNER OF THE DEVICE SITE. THE DEVICE WAS EXPLANTED ON (B)(6) 2010, AND THE ELECTRODES AND EXTENSIONS WERE LEFT IN PLACE. IT WAS STATED, THE PATIENT HAD AN INFECTION, AND THE PATIENT'S TREMOR SYMPTOMS HAD RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA PC | MHY | MEDTRONIC NEUROMODULATION | 37601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |