FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS LEAD MRI SURESCAN
MDR report key: 8784360
·
Received July 12, 2019
Report
- Report Number
- 2649622-2019-12086
- Event Type
- Injury
- Date Received
- July 12, 2019
- Date of Event
- July 8, 2019
- Report Date
- August 2, 2019
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00643169448896
- 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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 578127 | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 | 00643169448896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| R | 5076-58 LEAD, A2DR01 IPG |