FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 6009367
·
Received October 6, 2016
Report
- Report Number
- 2649622-2016-13410
- Event Type
- Injury
- Date Received
- October 6, 2016
- Date of Event
- July 21, 2016
- Report Date
- July 21, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL DEVICES: 5092-52 LEAD, IMPLANTED: (B)(6) 2010.
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 THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO CHEST STIMULATION. CAPTURE WAS UNABLE TO BE DETERMINED ON THE RIGHT ATRIAL (RA) LEAD. A LEAD DISLODGEMENT WAS CONFIRMED. THE LEAD WAS REPROGRAMMED AND 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 |
|---|---|---|---|---|---|---|---|
| 655971 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention | ADDR01 IPG |