FDA Adverse Event
Malfunction
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 2965154
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-01743
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- December 28, 2012
- Report Date
- February 27, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
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 PATIENT HAD A SUSPECTED RIGHT VENTRICULAR (RV) PERFORATION AND PERICARDIAL EFFUSION. THE RV LEAD WAS REMOVED. DURING THE IMPLANT ATTEMPT OF THE REPLACEMENT RV LEAD, THERE WAS UNRESOLVABLE SENSING AND NOISE. A DIFFERENT LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68723 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR | Hospitalization| L| R |