SPRINT QUATTRO SECURE S
Report
- Report Number
- 2649622-2011-02705
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S039
- Removal / Correction Number
- Z-0474-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
THIS EVENT OCCURRED OUTSIDE THE US. 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.
THIS EVENT OCCURRED OUTSIDE THE US. 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. THE (B)(4)DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): DISTAL CONDUCTOR FRACTURED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE INNTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM; DISTAL SEGMENT RETURNED AND ANALYZED. LEAD/MEDT: DISTAL CONDUCTOR FRACTURED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE INNTER TUBING WAS KINKED/BUCKLED, ALL INSULATORS WERE BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD WAS STRETCHED; DISTAL SEGMENT RETURNED AND ANALYZED.
THIS EVENT OCCURRED OUTSIDE THE US. 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. THE (B)(4) DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE RETURNED LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
IT WAS REPORTED THE PATIENT WAS ADMITTED TO HOSPITAL FOR SHOCKS ON THE DEVICE THAT APPEARED TO BE INAPPROPRIATE THAT WERE INITIATED BY OVERSENSING ON THE RV LEAD POSSIBLY THE RESULT OF LEAD FRACTURE. IT WAS FURTHER REPORTED THAT BOTH RV LEADS WERE FRACTURED. THE RV LEADS WERE EXTRACTED. A NEW RV LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THE PATIENT WAS ADMITTED TO HOSPITAL FOR SHOCKS ON THE DEVICE THAT APPEARED TO BE INAPPROPRIATE THAT WERE INITIATED BY OVERSENSING ON THE RV LEAD POSSIBLY THE RESULT OF LEAD FRACTURE. THE LEAD WILL BE EXTRACTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THE PATIENT WAS ADMITTED TO HOSPITAL FOR SHOCKS ON THE DEVICE THAT APPEARED TO BE INAPPROPRIATE THAT WERE INITIATED BY OVERSENSING ON THE RV LEAD POSSIBLY THE RESULT OF LEAD FRACTURE. IT WAS FURTHER REPORTED THAT BOTH RV LEADS WERE FRACTURED. THE RV LEADS WERE EXTRACTED. A NEW RV LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ANOTHER LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO SECURE S | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6935 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R | 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |