FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3990540
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08617
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 20, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. PRODUCTS: 5076-45 LEAD, IMPLANTED: 2002 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR (RV) LEAD HAS HIGH IMPEDANCE. 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 |
|---|---|---|---|---|---|---|---|
| 471993 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5092-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | ADDRS1 IPG |