FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 2964892
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-01965
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- December 28, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- K940703
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. CONCOMITANT PRODUCTS : (B)(4) HEART RING (B)(6) 1997; 4024 IMPLANTABLE PACING LEAD (B)(6) 1997. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WAS NOT SENSING P WAVES AND HAD LOW IMPEDANCE. THE LEAD WAS 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 |
|---|---|---|---|---|---|---|---|
| 67973 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4558M-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Hospitalization| R | ADDR01 IMPLANTABLE PACEMAKER |