FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 4162601
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12701
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- June 30, 2014
- Report Date
- July 10, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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. CONCOMITANT MEDICAL PRODUCTS: D154ATG ICD, IMPLANTED: (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD TREND HAD AN IMPEDANCE SPIKE FOR JUST ONE DAY. THE CAPTURE THRESHOLD WAS NOTED TO BE UNCHANGED. 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 |
|---|---|---|---|---|---|---|---|
| 644435 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | 694765 LEAD |