FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 3152417
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06833
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- April 11, 2013
- Report Date
- April 11, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, 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 PRODUCT: 507652 IMPLANTABLE PACING LEAD (B)(6) 2003. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A SENSING ISSUE ON THE ATRIAL LEAD AS NOTED BY THE ABSENCE OF AN ATRIAL EVENT FOLLOWED BY A VENTRICULAR PACE. REPROGRAMMING OF THE DEVICE WAS DONE AND THE LEAD 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 |
|---|---|---|---|---|---|---|---|
| 253100 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00095 YR | ADDR01 IMPLANTABLE PULSE GENERATOR |