FDA Adverse Event
Malfunction
Summary report: N
CAPSURE EPI
MDR report key: 2952146
·
Received February 9, 2013
Report
- Report Number
- 2182208-2013-00136
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 8, 2012
- Report Date
- November 8, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- DTB
- PMA / PMN Number
- P950024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
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 DURING A POST-OP CHECK FOLLOWING SYSTEM UPGRADE, THERE WAS A WARNING FOR HIGH ATRIAL IMPEDANCE. FURTHER MEASUREMENTS SHOWED NORMAL IMPEDANCE, AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56907 | CAPSURE EPI | ELECTRODE, PACEMAKER, PERMANENT | DTB | RICE CREEK MFG | 4968-35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR |