FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2203454
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11699
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 12, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR CONNECTOR PIN WAS BENT. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE ATRIAL LEAD'S HELIX DID NOT EXTEND GRADUALLY BUT POPPED OUT SUDDENLY. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS MRI | IMPLANTABLE PACING LEAD | NVN | MEDTRONIC PUERTO RICO, INC. | 5086MRI | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |