FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIXNOVUS
MDR report key: 2951549
·
Received February 9, 2013
Report
- Report Number
- 3008973940-2013-00003
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 2, 2012
- Report Date
- March 27, 2013
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT BEFORE THE IMPLANT PROCEDURE, DURING EXERCISE ON THE TABLE, THE HELIX SCREW OF THE LEAD WAS UNABLE TO BE EXTENDED. THE LEAD WAS NOT USED FOR THE PROCEDURE AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57361 | CAPSUREFIXNOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC SINGAPORE OPERATIONS | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |