FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3151530
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-05499
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- March 7, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. PRODUCTS: VEDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2009; 5076-58 IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE RIGHT VENTRICULAR (RV) IMPLANTABLE PACING LEAD WAS FRACTURED AND THERE WAS NOISE ON THE RIGHT ATRIUM (RA) IMPLANTABLE PACING LEAD. BOTH LEADS WERE CAPPED 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 |
|---|---|---|---|---|---|---|---|
| 252199 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Hospitalization| R |