FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 2062454
·
Received April 12, 2011
Report
- Report Number
- 3007566237-2011-02758
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 17, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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
IT WAS REPORTED THAT THE PT WAS UNABLE TO ADJUST STIMULATION WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THAT THE INS DISPLAYED A "CALL YOUR DOCTOR" OUT OF REGULATION MESSAGE. THE ISSUE WAS RESOLVED UPON REINTERROGATION THE INS, AFTER WHICH IT APPEARED TO BE FUNCTIONING NORMALLY. THE HEALTH CARE PROFESSIONAL AND A MFR REP BELIEVED THAT THE MESSAGE WAS DUE TO ELECTROMAGNETIC INTERFERENCE. PT AND DEVICE INFO COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO 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 |