FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS LEAD MRI SURESCAN
MDR report key: 11317695
·
Received February 11, 2021
Report
- Report Number
- 2649622-2021-02787
- Event Type
- Malfunction
- Date Received
- February 11, 2021
- Date of Event
- January 3, 2019
- Report Date
- February 11, 2021
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00681490124799
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: A2DR01 IPG IMPLANT DATE: (B)(6) 2017; 4351-35 GASTRIC MGU LEAD IMPLANT DATE: (B)(6) 2019; 4351-35 GASTRIC MGU LEAD IMPLANT DATE: (B)(6) 2019; 37800 GASTRIC MGU IPG IMPLANT DATE: (B)(6) 2019 . 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 POSSIBLE UNDER-SENSING ON STORED ELECTROGRAMS (EGMS). 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 |
|---|---|---|---|---|---|---|---|
| 209439 | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 | 00681490124799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |