FDA Adverse Event
Malfunction
Summary report: N
CAPSURE Z NOVUS
MDR report key: 3278899
·
Received August 10, 2013
Report
- Report Number
- 2649622-2013-10491
- Event Type
- Malfunction
- Date Received
- August 10, 2013
- Date of Event
- May 2, 2013
- Report Date
- June 27, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 MEDICAL PRODUCTS: 5076, IMPLANTABLE PACING LEAD, (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DEVICE REPLACEMENT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS NICKED DURING THE DEVICE CHANGEOUT. SINCE THEN, THE PATIENT HAS COMPLAINED OF FEELING A 'ZING' NEAR THE IMPLANT EVERY DAY. 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 |
|---|---|---|---|---|---|---|---|
| 383248 | CAPSURE Z NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5054-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | P1501DR IMPLANTABLE PACEMAKER |