FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3152605
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06737
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- April 16, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. NO ANOMALIES WERE FOUND. CONCOMITANT PRODUCT: 6944, IMPLANTABLE TACHY LEAD, (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING AS WELL AS UNDERSENSING. THE LEAD SENSITIVITY WAS REPROGRAMMED, AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252821 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention | D314DRG IMPLANTABLE DEFIBRILLATOR |