FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3860900
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-06825
- 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
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE 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 PRODUCTS: 429678 LEAD, IMPLANTED 2013 (B)(6); 693558 LEAD, IMPLANTED: 2013 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INTERROGATION SHOWED THE RIGHT ATRIAL (RA) LEAD OBSERVED WITH P-WAVE UNDERSENSING. THE RA LEAD REMAINS IN USE. IT WAS ALSO SHOWED THAT THE RIGHT VENTRICULAR (RV) LEAD OBSERVED WITH T-WAVE OVERSENSING (TWOS). THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342490 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | (B)(4) ICD |