FDA Adverse Event
Malfunction
Summary report: N
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
MDR report key: 3151706
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-05647
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- January 1, 2013
- Report Date
- March 1, 2013
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P060039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. THE PATIENT EXPERIENCED DIAPHRAGMATIC MUSCLE STIMULATION. THERE WAS NO ACTION TAKEN AND THE LEAD REMAINED 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 |
|---|---|---|---|---|---|---|---|
| 253150 | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419588C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR |