FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 6007531
·
Received October 6, 2016
Report
- Report Number
- 2649622-2016-12441
- Event Type
- Injury
- Date Received
- October 6, 2016
- Date of Event
- August 8, 2016
- Report Date
- August 8, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE MONTH POST IMPLANT, THE PATIENT SUFFERED A FALL THAT RESULTED IN DISLODGEMENT AND NO CAPTURE OF THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS. THE LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 660607 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Hospitalization| R | A2DR01 IPG, 5076-52 LEAD |