FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 4862497
·
Received June 23, 2015
Report
- Report Number
- 2649622-2015-07697
- Event Type
- Malfunction
- Date Received
- June 23, 2015
- Date of Event
- January 7, 2015
- Report Date
- June 18, 2015
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD 79 HIGH IMPEDANCE COUNTS AND A POLARITY SWITCH TO THE UNIPOLAR PACING CONFIGURATION OCCURRED. THE UNIPOLAR IMPEDANCE AND THRESHOLD WERE NOTED TO BE WITHIN LIMITS AND NO FALSE HIGH RATE EPISODES, NOR NOISE WAS SEEN. THE PHYSICIAN WILL BE CONSULTED AND THE LEAD 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 |
|---|---|---|---|---|---|---|---|
| 406393 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00007 MO | 5076-45 LEAD, ADDRL1 IPG |