FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS MRI SURESCAN
MDR report key: 8901385
·
Received August 16, 2019
Report
- Report Number
- 2649622-2019-14494
- Event Type
- Malfunction
- Date Received
- August 16, 2019
- Date of Event
- May 18, 2019
- Report Date
- August 16, 2019
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00885074200682
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: 4968-60, LEAD IMPLANT DATE: (B)(6) 2008, 694765 LEAD IMPLANT DATE: (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 EXHIBITED INTERMITTENT 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 |
|---|---|---|---|---|---|---|---|
| 695947 | CAPSUREFIX NOVUS MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407652 | 00885074200682 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | DTBB1D1 ICD |