FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 2791326
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-15429
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- August 22, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVY
- PMA / PMN Number
- P920015/S055
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 AND ANALYZED; ANALYSIS REVEALED THE HELIX WAS BLOCKED BY THE GUIDE TOOTH. THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD WAS DAMAGED AT IMPLANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE LEAD WAS ATTEMPTED BUT NOT USED BECAUSE THE HELIX WOULD NOT EXTEND. 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 |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO SECURE | IMPLANTABLE TACHY LEAD | NVY | MEDTRONIC PUERTO RICO, INC. | 6947M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |