FDA Adverse Event
Injury
Summary report: N
KAPPA 900 DR
MDR report key: 4162515
·
Received October 10, 2014
Report
- Report Number
- 9614453-2014-02519
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 13, 2014
- Report Date
- August 14, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DXY
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
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).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE TRIGGERED AN ALERT FOR THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE, HOWEVER UPON MEASUREMENT THROUGH THE ANALYZER, THE RV LEAD IMPEDANCE WAS NOTED AS WITHIN NORMAL LIMITS. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643483 | KAPPA 900 DR | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | IPG MFG SWITZERLAND | KDR931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |