BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3153064 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05801
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6949 IMPLANTABLE DEFIBRILLATION LEAD, (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE LEAD HELIX WOULD NOT EXTEND WHILE IN THE PATIENT. THE PHYSICIAN WAS STILL UNABLE TO EXTEND THE HELIX OF THE ATTEMPTED LEAD ON THE TABLE. THE LEAD WAS NOT USED. THE PATIENT'S SUPERIOR VENA CAVA (SVC) WAS VERY TIGHT SO THE DECISION WAS MADE TO NOT REPLACE THE RIGHT VENTRICULAR LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS NOTED TO BE PART OF THE (B)(6) STUDY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE LEAD HELIX WOULD NOT EXTEND WHILE IN THE PATIENT. THE PHYSICIAN WAS STILL UNABLE TO EXTEND THE HELIX OF THE ATTEMPTED LEAD ON THE TABLE. THE LEAD WAS NOT USED. THE PATIENT'S SUPERIOR VENA CAVA (SVC) WAS VERY TIGHT SO THE DECISION WAS MADE TO NOT REPLACE THE RIGHT VENTRICULAR LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256176 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR 5072 IMPLANTABLE PACING LEAD