FDA Adverse Event
Malfunction
Summary report: N
TBD
MDR report key: 2954688
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-02380
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Report Date
- December 20, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4) IMPLANTABLE PACING LEAD (B)(6) 1999. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAD WARNING FOR ATRIAL LEAD IMPEDANCE WAS TRIGGERED AND THAT THERE WAS A POLARITY SWITCH TO UNIPOLAR PACING. THE LEAD WILL CONTINUE TO BE MONITORED AND 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 |
|---|---|---|---|---|---|---|---|
| 58618 | TBD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5592-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) IMPLANTABLE PULSE GENERATOR |