FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3153438
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06020
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 29, 2013
- Report Date
- March 29, 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
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE, AFTER THE LEAD WAS PLACED, IT WAS NOTED THAT THE LEAD WAS EXPIRED. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 257266 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR |