FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS LEAD MRI SURESCAN
MDR report key: 8663480
·
Received June 3, 2019
Report
- Report Number
- 2649622-2019-09457
- Event Type
- Injury
- Date Received
- June 3, 2019
- Date of Event
- November 1, 2018
- Report Date
- October 7, 2019
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00643169633742
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 LOW SENSING AND INSULATION ISSUE. THE RA LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THEY EXPERIENCED SHOCKS IN THEIR ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457037 | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 | 00643169633742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R | W1DR01 IPG, 5076-52 |