FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SENSE
MDR report key: 2964539
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-02046
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- December 10, 2012
- Report Date
- April 1, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY #(B)(4) - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PHYSICIAN TRIED SEVERAL POSITIONS TO PLACE THE LEAD WITHOUT GOOD PARAMETERS. THE LEAD WAS NOT USED AND A NEW 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 |
|---|---|---|---|---|---|---|---|
| 67994 | CAPSURE SENSE | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 457453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |