FDA Adverse Event
Injury
Summary report: N
KAPPA 900 DR
MDR report key: 2964808
·
Received February 15, 2013
Report
- Report Number
- 9614453-2013-00443
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- November 15, 2012
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DXY
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD THRESHOLDS HAD INCREASED AND THE IMPEDANCE VALUE WAS HIGH. THE DEVICE WAS AT MAXIMUM OUTPUT. THE DEVICE AND LEAD WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67605 | KAPPA 900 DR | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | IPG MFG SWITZERLAND | KDR933 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00033 YR | Hospitalization| R | 5034 IMPLANTABLE PACING LEAD |