FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 3092224
·
Received May 3, 2013
Report
- Report Number
- 3004209178-2013-07262
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Report Date
- April 17, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE RIGHT SIDE THERAPY IMPEDANCES WERE GREATER THAN 4000 OHMS AND THE CURRENT WAS LESS THAN 15 MA, BUT THE INDIVIDUAL ELECTRODE IMPEDANCES WERE NORMAL. THE AMPLITUDE SETTING WAS REPORTED AS 9.2 V. NO CHANGES IN SYMPTOMS WERE REPORTED. IT WAS LATER REPORTED NO HISTORICAL THERAPY MEASUREMENTS WERE COLLECTED. THE PATIENT HAD NOT HAD ANOTHER DEVICE INTERROGATION SINCE (B)(6) 2013, WHEN THE PRIOR INTERROGATION OCCURRED. THE PATIENT WAS ASYMPTOMATIC. IT WAS REPORTED NO INTERVENTIONS WERE NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193916 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |