FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1874643
·
Received October 19, 2010
Report
- Report Number
- 2649622-2010-11470
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 17, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO IMPLANT, THE LEAD PIN WAS NOTED TO MOVE AWAY FROM THE DISTAL EDGE OF THE SEALING RING, AND THE HELIX WAS NARROWED. IT WAS FURTHER REPORTED THAT THERE WAS MORE "PLAY" IN THE PIN, AND IT COULD BE MOVED IN AND OUT IN AN UNEXPECTED MANNER. THE LEAD WAS NOT IMPLANTED. THE ISSUE WAS DETECTED PRIOR TO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |