FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SENSE
MDR report key: 3160432
·
Received June 10, 2013
Report
- Report Number
- 2649622-2013-07986
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Report Date
- June 17, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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. CONCOMITANT PRODUCTS: 457453 IMPLANTABLE PACING LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT FELT UNCOMFORTABLE AND WAS SEEN AT THE HOSPITAL. EXAMINATION REVEALED THAT THERE WAS A LEAD DISLODGEMENT. THE STATUS OF THE LEAD IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED INTERVENTION FOR THE DISLODGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259563 | CAPSURE SENSE | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407458 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) |