FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 3051017
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04780
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- February 19, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- 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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2005-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED AT GENERATOR CHANGE THE VENTRICULAR LEAD WAS CAPPED AND REPLACED DUE TO DECREASED IMPEDANCE AND INCREASED THRESHOLD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153345 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407452 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Hospitalization| L| R | (B)(4) IMPLANTABLE PACEMAKER |