FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 3113507
·
Received May 15, 2013
Report
- Report Number
- 9614453-2013-01051
- Event Type
- Malfunction
- Date Received
- May 15, 2013
- Report Date
- May 2, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- 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).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING A BATTERY AND POCKET ADAPTOR REPLACEMENT (SEE MFR. REP. # 3007566237-2013-00041), IMPEDANCE MEASUREMENTS WERE NOT NORMAL. IT WAS NOTED THAT MONOPOLAR READINGS WERE HIGH HIGHER THAN BIPOLAR READINGS AND THERE WERE LOW IMPEDANCES ON (B)(6). THE HCP WAS AWARE TO NOT PROGRAM THE PATIENT ON THOSE CONTACTS TO AVOID EARLY ERI, AND IT WAS NOTED THAT IF THERAPY WAS NOT SATISFYING FOR THE PATIENT, THE LEAD WOULD HAVE TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214734 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | IPG MFG SWITZERLAND | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |