FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2951871
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00278
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- April 8, 2012
- Report Date
- February 22, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039/S017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY (B)(4) - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. HOWEVER, APPARENT EXPLANT DAMAGE WAS NOTED. (B)(4) - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. HOWEVER, APPARENT EXPLANT DAMAGE WAS NOTED.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6947 IMPLANTABLE DEFIBRILLATING LEAD 2012 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT BOTH THE RIGHT VENTRICULAR AND THE ATRIAL LEADS DISLODGED. BOTH LEADS WERE 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 |
|---|---|---|---|---|---|---|---|
| 56684 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00033 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC |