FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3991793
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-07951
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 2, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS ATTEMPTED TO IMPLANT IN THE RIGHT VENTRICLE (RV) BUT NOT USED. THE LEAD WAS FOUND TO HAVE HIGH IMPEDANCE. ALSO, THE HELIX WOULD EXTEND RAPIDLY AFTER ONLY FOUR TURNS. A NEW LEAD WAS USED TO IMPLANT SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467224 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00087 YR |