FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3990522
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08606
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 20, 2014
- Report Date
- May 21, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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 PRODUCT: ADDR01 IPG IMPLANTED 2014 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ONE DAY AFTER AN IMPLANT PROCEDURE, THE RIGHT ATRIAL AND RIGHT VENTRICULAR (RV) LEADS WERE FOUND TO BE REVERSED IN THE DEVICE HEADER. THE DEVICE WAS REPROGRAMMED TO AN ATRIAL PACING MODE TO ENSURE RV CAPTURE. THE SYSTEM 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 |
|---|---|---|---|---|---|---|---|
| 468578 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Required Intervention | 5076-52 LEAD |