FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 5859548
·
Received August 9, 2016
Report
- Report Number
- 2649622-2016-08784
- Event Type
- Injury
- Date Received
- August 9, 2016
- Date of Event
- December 1, 2015
- Report Date
- May 16, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 THAT A RIGHT ATRIAL (RA) LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HIGH IMPEDANCE. IN ADDITION, THE RA LEAD EXHIBITED INTERMITTENT CAPTURE AND NOISE WAS NOTED ON AN ELECTROGRAM. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508463 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R |