FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SENSE
MDR report key: 3991670
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08010
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 5, 2014
- Report Date
- May 5, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). THE BATTERY LONGEVITY WAS LESS THAN EXPECTED. A NEW DEVICE WAS IMPLANTED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAS HIGH THRESHOLDS. 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 |
|---|---|---|---|---|---|---|---|
| 472696 | CAPSURE SENSE | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 457453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | D224TRK ICD, 6944-65 LEAD, 1258T LEAD |