FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 4163280
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12395
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- August 13, 2014
- Report Date
- August 14, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY:THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES WERE FOUND. OF NOTE, THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BLOOD.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE BEING USED AS A TEMPORARY PACING LEAD, THE LEAD HELIX WOULD NOT EXTEND OR RETRACT PROPERLY. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 644656 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |