BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2203557 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01337
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD) AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    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 THE RIGHT VENTRICULAR LEAD'S IMPEDANCE HAS BEEN HIGH AND FLUCTUATING. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS CAPPED. ALSO, DURING THE LEAD REVISION PROCEDURE A SINGLE COIL RIGHT VENTRICULAR LEAD WAS ATTEMPTED TO BE PLACED BUT FAILED DFTS (DEFIBRILLATION THRESHOLD). THIS LEAD WAS THEN REMOVED AND A NEW LEAD WAS IMPLANTED INSTEAD. FOLLOW-UP WAS ALSO CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT THE RIGHT VENTRICULAR HIGH SVC (SUPERIOR VENA CAVA) LEAD HAD HIGH THRESHOLDS. THIS LEAD WAS CAPPED AT THE SAME TIME AS THE RIGHT VENTRICULAR APEX LEAD AND BOTH LEADS WERE REPLACED WITH ONE DUAL COIL RIGHT VENTRICULAR LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD'S IMPEDANCE HAS BEEN HIGH AND FLUCTUATING. THE LEAD REMAINS IN USE. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6933 IMPLANTABLE TACHY LEAD