FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 8327884
·
Received February 11, 2019
Report
- Report Number
- 2649622-2019-02223
- Event Type
- Injury
- Date Received
- February 11, 2019
- Date of Event
- January 17, 2019
- Report Date
- March 12, 2019
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00681490124812
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: 694765 LEAD, IMPLANTED: (B)(6) 2009, DTBA1D1 ICD, IMPLANTED: (B)(6) 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE RA LEAD WAS REPROGRAMMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS UNDERSENSING. IT WAS ALSO REPORTED THAT DIMINISHED P-WAVES WERE NOTED ON THE RA LEAD. 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 |
|---|---|---|---|---|---|---|---|
| 121662 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 | 00681490124812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |