FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 6923882
·
Received October 6, 2017
Report
- Report Number
- 2649622-2017-11670
- Event Type
- Injury
- Date Received
- October 6, 2017
- Date of Event
- August 8, 2017
- Report Date
- August 8, 2017
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: 694765 LEAD, IMPLANTED: (B)(6) 2013.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD SMALL P-WAVES AND OCCASIONAL OVERSENSING LEADING TO INAPPROPRIATE MODE SWITCH EPISODES. DURING A ROUTINE GENERATOR CHANGE-OUT PROCEDURE, IT WAS NOTED THAT THE RA LEAD HAD AN INSULATION BREACH NEAR THE TERMINAL PIN. THE RA LEAD WAS REPAIRED WITH MEDICAL ADHESIVE AND A SUTURE SLEEVE. THE RA LEAD WAS REPROGRAMMED 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 |
|---|---|---|---|---|---|---|---|
| 701389 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Hospitalization| R |