FDA Adverse Event
Malfunction
Summary report: N
CAPSURE Z NOVUS
MDR report key: 3861662
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07204
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- April 19, 2014
- Report Date
- April 19, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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 MEDICAL PRODUCTS: 5554-45 LEAD, IMPLANTED (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS UNDERSENSING P-WAVES AND THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING PACING AND SENSING IRREGULARITIES. 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 |
|---|---|---|---|---|---|---|---|
| 341974 | CAPSURE Z NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5054-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR | ADDR01 IPG |