FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 8375301
·
Received February 27, 2019
Report
- Report Number
- 2649622-2019-03262
- Event Type
- Malfunction
- Date Received
- February 27, 2019
- Date of Event
- January 30, 2019
- Report Date
- March 11, 2019
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00885074248448
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
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: ADDR01 IPG IMPLANTED (B)(6) 2017. 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 PATIENT HAD NEAR SYNCOPE. IT WAS ALSO REPORTED THAT THE RA LEAD WAS INTERMITTENTLY OVERSENSING ON PRESENTING AND STORED ELECTROGRAMS (EGM). THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166877 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5568-45 | 00885074248448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention | ELA MEDICAL LEAD |