FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 2953059
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00880
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- November 21, 2012
- Report Date
- November 22, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
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). CONCOMITANT PRODUCTS: 5554 IMPLANTABLE PACING LEAD 2010 (B)(6).
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 BOTH THE VENTRICULAR AND ATRIAL LEAD THRESHOLDS WERE HIGH AND UNSTABLE. THE LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57036 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5054-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR |