FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3862168
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07030
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- April 24, 2014
- Report Date
- April 24, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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. CONCOMITANT: 6947-65 LEAD IMPLANTED: 2011-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE P-WAVE HAD DECREASED AND THERE WAS INTERMITTENT UNDERSENSING ON THE ATRIAL LEAD. THE RIGHT VENTRICULAR LEAD WAS ALSO NOTED TO HAVE INTERMITTENT T-WAVE OVERSENSING. THE VENTRICULAR SENSITIVITY WAS REPROGRAMMED. BOTH LEADS REMAIN 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 |
|---|---|---|---|---|---|---|---|
| 337375 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00057 YR | D314DRG ICD |