FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 6625578
·
Received June 8, 2017
Report
- Report Number
- 2649622-2017-05761
- Event Type
- Injury
- Date Received
- June 8, 2017
- Date of Event
- April 13, 2017
- Report Date
- April 13, 2017
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00681490124812
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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 THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD BECOME FRACTURED. THE RV LEAD EXHIBITED NO CAPTURE, OVERSENSING, INFINITE IMPEDANCE, AND A POLARITY SWITCH. THE RV LEAD WAS PROGRAMMED OFF AND REMAINS IN THE PATIENT. THE PHYSICIAN ELECTED TO CHANGE THE DEVICE MODE TO AIR, SINCE VENTRICULAR PACING WAS NOT NEEDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403009 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 | 00681490124812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |