FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2790455
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14735
- Event Type
- Injury
- Date Received
- October 15, 2012
- Report Date
- August 17, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED AND NO ANOMALIES FOUND. APPARENT EXPLANT DAMAGE WAS NOTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS DETECTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE EXTRACTION OF THE RV LEAD THE ATRIAL LEAD CAME OUT, AND SUBSEQUENTLY WAS ALSO EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R | 1861 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD |