FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS MRI SURESCAN
MDR report key: 12317573
·
Received August 13, 2021
Report
- Report Number
- 2649622-2021-16465
- Event Type
- Injury
- Date Received
- August 13, 2021
- Date of Event
- August 6, 2021
- Report Date
- August 13, 2021
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00643169708198
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCT: 305U27 TISSUE VALVE WAS IMPLANTED ON (B)(6) 2008. 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 HAD FRACTURED. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED NO CAPTURE AND HIGH IMPEDANCE. IT WAS ALSO NOTED THAT THE RA WAS UNDER-SENSING AND NO ATRIAL SENSING OF INTRINSIC EVENTS AT LOWEST SENSITIVITY WAS OBSERVED. THE RA LEAD WAS 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 |
|---|---|---|---|---|---|---|---|
| 1218795 | CAPSUREFIX NOVUS MRI SURESCAN | PERMANENT PACEMAKER ELECTRODE | DTB | MPRI | 407652 | 00643169708198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R | L121 IPG, 407658 LEAD |