FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 2050125
·
Received April 1, 2011
Report
- Report Number
- 3007566237-2011-02476
- Event Type
- Malfunction
- Date Received
- April 1, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 15, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S DEVICE WAS SHOWING LOW IMPEDANCE READINGS. IT WAS STATED BY A HEALTH CARE PROVIDER THAT "SHE WAS TOLD THAT LEAD END WAS DAMAGED SO SURGEON CUT OFF ELECTRODE #3 AND STILL PLACED IN EXTENSION." ALL IMPEDANCE READINGS INVOLVING ELECTRODE #3 WERE OPEN. IT WAS STATED THE PT'S DEVICE SETTINGS DID NOT INCLUDE ELECTRODE #3, AND THE PT WAS RECEIVING GOOD SYMPTOMS CONTROL. PT INFORMATION WAS DENIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 |