FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 2990168
·
Received March 5, 2013
Report
- Report Number
- 3007566237-2013-00678
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Date of Event
- February 13, 2013
- Report Date
- February 13, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT EVERYTHING WAS "OK" AND THE PATIENT OUTCOME WAS ALSO NOTED AS "OK." NO ADDITIONAL INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT ENCOUNTERED A 509 ERROR CODE ON THEIR PATIENT PROGRAMMER FOLLOWED BY A LOSS OF STIMULATION THERAPY. THE PATIENT WAS PROGRAMMED ON MULTIPLE GROUPS. IT WAS STATED THAT THE PATIENT HAD CHANGED A GROUP WITH THE PROGRAMMER AND THEN THE STIMULATION STOPPED. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93437 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |