FDA Adverse Event
Injury
Summary report: N
CAPSURE SENSE
MDR report key: 3863299
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-06663
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- April 24, 2014
- Report Date
- June 16, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: DATE OF EVENT FROM (B)(6) 2014 TO (B)(6) 2014.
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCTS: 457453 LEAD IMPLANTED: 2014 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE LEAD WAS REPROGRAMMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLDS AND NO CAPTURE. DIAGNOSTICS REVEALED THAT THE RV LEAD HAD PERFORATED THE VENTRICLE. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT IS ENROLLED IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341365 | CAPSURE SENSE | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407458 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Hospitalization| R | SEDRL1 IPG |