FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 6160537
·
Received December 9, 2016
Report
- Report Number
- 2649622-2016-14177
- Event Type
- Injury
- Date Received
- December 9, 2016
- Date of Event
- October 5, 2016
- Report Date
- October 5, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00643169550773
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED TEN DAYS AFTER IMPLANT THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD HIGH PACING THRESHOLDS. THE RV LEAD WAS REVISED AND 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 |
|---|---|---|---|---|---|---|---|
| 808488 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 | 00643169550773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| R | (B)(4) IPG, 5076-45 LEAD |