FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SENSE
MDR report key: 3992748
·
Received August 8, 2014
Report
- Report Number
- 3008973940-2014-00322
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 6, 2014
- Report Date
- June 11, 2014
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY : THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEAD COULD NOT BE TESTED IN THE BIPOLAR PACING CONFIGURATION. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471507 | CAPSURE SENSE | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC SINGAPORE OPERATIONS | 407458 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |