FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3990018
·
Received August 7, 2014
Report
- Report Number
- 2649622-2014-08855
- Event Type
- Malfunction
- Date Received
- August 7, 2014
- Date of Event
- June 17, 2014
- Report Date
- June 17, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN HAD DIFFICULTY PLACING THE PASSIVE FIXATION RIGHT VENTRICULAR (RV) LEAD DUE TO THE PATIENTS SIGNIFICANT TRICUSPID REGURGITATION. THE PASSIVE LEAD WAS REMOVED AND AN ACTIVE FIXATION LEAD WAS PLACED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462714 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5092-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00087 YR |