FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS LEAD MRI SURESCAN
MDR report key: 8929262
·
Received August 26, 2019
Report
- Report Number
- 2649622-2019-15147
- Event Type
- Injury
- Date Received
- August 26, 2019
- Date of Event
- July 31, 2019
- Report Date
- August 26, 2019
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00681490124799
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: 694758 LEAD, IMPLANTED: (B)(6) 2003, 5071-53 LEAD IMPLANTED: (B)(6) 2003. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WIL,L BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED INTO THE RIGHT VENTRICLE. THE RA LEAD WAS CAPPED 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 |
|---|---|---|---|---|---|---|---|
| 725642 | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 | 00681490124799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| R | DTBA1D1 CRT-D |