FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 2953057
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00875
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 21, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
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)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD IMPEDANCE DECREASED OVER TIME. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVEBEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56077 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4568-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 4092 IMPLANTABLE PACING LEAD |