FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3153460
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06021
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 5, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE, THE LEAD HAD HIGH THRESHOLDS. THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258817 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00057 YR |