FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3990346
·
Received August 7, 2014
Report
- Report Number
- 2649622-2014-08686
- Event Type
- Malfunction
- Date Received
- August 7, 2014
- Date of Event
- June 28, 2014
- Report Date
- June 28, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A IMPLANTABLE PACING LEAD WAS PLACED AT THE TARGET LOCATION. THE LEAD WAS TESTED AND EXHIBITED HIGH THRESHOLD AND NO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463637 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR |