FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 6006074
·
Received October 6, 2016
Report
- Report Number
- 2649622-2016-11704
- Event Type
- Injury
- Date Received
- October 6, 2016
- Date of Event
- June 29, 2016
- Report Date
- July 15, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
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 A LEAD FRACTURE WAS SUSPECTED ON THE RIGHT ATRIAL (RA) LEAD. IT WAS NOTED THAT A REMOTE TRANSMISSION APPROXIMATELY TWO WEEKS PRIOR HAD INDICATED AN ATRIAL POLARITY SWITCH AND HIGH IMPEDANCE. DURING A DEVICE CHECK, ATRIAL UNIPOLAR AND BIPOLAR IMPEDANCES WERE INFINITE AND NO CAPTURE OR SENSING WERE NOTED. THE PATIENT DID NOT DISPLAY SYMPTOMS AND A CHEST X-RAY COULD NOT IDENTIFY A DEFINITE FRACTURE. THE LEAD WAS TURNED OFF AND THE PATIENT WILL CONTINUE TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 658104 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | ADDR01 IPG, 5076-52 LEAD |