FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS MRI SURESCAN
MDR report key: 13471962
·
Received February 7, 2022
Report
- Report Number
- 2649622-2022-02616
- Event Type
- Malfunction
- Date Received
- February 7, 2022
- Date of Event
- October 12, 2021
- Report Date
- February 7, 2022
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00643169708198
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CONCOMITANT MEDICAL PRODUCTS: 6935M55 LEAD, IMPLANTED: (B)(6) 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 0
CONCOMITANT MEDICAL PRODUCTS: 6935M55 LEAD, IMPLANTED: (B)(6) 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1497139 | CAPSUREFIX NOVUS MRI SURESCAN | PERMANENT PACEMAKER ELECTRODE | DTB | MPRI | 407652 | 00643169708198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Male | DTMA1QQ CRTD, 429888 LEAD |