FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1202083
·
Received October 16, 2008
Report
- Report Number
- 3004209178-2008-06614
- Event Type
- Malfunction
- Date Received
- October 16, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 19, 2008
- Manufacturer
- MEDTRONIC PUEROT RICO OPERAITONS CO.
- 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
INVALID IMPEDANCE MEASUREMENTS AND LOW CURRENT, CAUSE NOT SPECIFIED.
Description of Event or Problem · 1
THE CURRENT OF THE RIGHT SIDED LEAD WAS LESS THAN 15 MICROAMPERES, INDICATING AN OPEN CIRCUIT. THERAPY IMPEDANCES FOR THE RIGHT SIDED LEAD WERE GREATER THAN 400 OHM MEASURED AT 2.5 VOLTS. EXHAUSTIVE IMPEDANCE TESTING REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SOME BIPOLAR PAIRS. ALL OTHER BIPOLAR IMPEDANCE MEASUREMENTS WERE NORMAL. STIMULATION STATUS AND SYMPTOM SUPPRESSION INFORMATION WAS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC PUEROT RICO OPERAITONS CO. | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | LEAD: MODEL 3387S| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| EXTENSION: MODEL 7482| EXPLANTED:| LEAD, MODEL 3387S| IMPLANTED:| EXPLANTED: |