FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 6164067
·
Received December 9, 2016
Report
- Report Number
- 2649622-2016-15929
- Event Type
- Malfunction
- Date Received
- December 9, 2016
- Date of Event
- October 24, 2016
- Report Date
- October 25, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00643169550766
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
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 THE LEAD DISPLAYED UNDER SENSING DURING AN ARRHYTHMIA. THE LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 809422 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 | 00643169550766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | DDMB1D4 ICD, 6935M62 LEAD |