BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2130719 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10219
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. NORMAL BATTERY DEPLETION WAS FOUND. (B)(4): NO ANOMALIES FOUND, HOWEVER THE DEFIBRILLATION COIL WAS DISTORTED, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE; FULL LEAD RETURNED AND ANALYZED.

    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 DEVICE WAS RETURNED AND ANALYZED. NORMAL BATTERY DEPLETION WAS FOUND. (B)(4): NO ANOMALIES FOUND, HOWEVER THE DEFIBRILLATION COIL WAS DISTORTED, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE; FULL LEAD RETURNED AND ANALYZED. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND HOWEVER THE INNER TUBING WAS KINKED/BUCKLED; THE OUTER TUBING OVERLAY WAS BREACHED CUT. THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY AND BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE MECHANISM (SLEEVE HEAD). THERE WAS ALSO APPARENT IMPLANT DAMAGE. FURTHER INFORMATION INDICATED THAT THE CHRONIC LEAD WAS NOT REPOSITIONED. THE CHRONIC LEAD WAS REMOVED AND REPLACED DUE THE HIGH THRESHOLDS CAUSING EARLY BATTERY DEPLETION. THE REPLACEMENT LEAD HAD POSITIONING DIFFICULTIES AND THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM THREE TIMES FOR POSITIONING ATTEMPTS. DURING THE ATTEMPTS, THE LEAD SHOWED THE HIGH THRESHOLDS, HIGH IMPEDANCES, T-WAVE OVERSENSING AND NO CAPTURE. IT WAS NOTED THAT DURING ONE OF THE REPOSITIONING ATTEMPTS, THE HELIX WOULD NO LONGER EXTEND. THE LEAD WAS REMOVED AND A NEW LEAD IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ELECTIVE REPLACEMENT INDICATOR DID NOT TRIGGER AND THE DEVICE HAD EARLY BATTERY DEPLETION. IT WAS FURTHER REPORTED THAT THE CHRONIC VENTRICULAR LEAD SHOWED HIGH IMPEDANCES AND THRESHOLDS AND REPOSITIONING WAS ATTEMPTED TWO TIMES WITH TWO SEPARATE PROCEDURES WITHOUT SUCCESS. THE DEVICE AND CHRONIC LEAD WERE EXPLANTED AND THE DEVICE WAS REPLACED. DURING THE REPLACEMENT PROCEDURE, A NEW LEAD TO REPLACE THE CHRONIC LEAD WAS ATTEMPTED TO BE IMPLANTED, BUT SHOWED HIGH THRESHOLDS, HIGH IMPEDANCES, T-WAVE OVERSENSING, NO CAPTURE, AND THE HELIX WAS RETRACTED AND WOULDN'T EXTEND, BUT WOULD ABRUPTLY SPRING OUT. THIS LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ELECTIVE REPLACEMENT INDICATOR DID NOT TRIGGER AND THE DEVICE HAD EARLY BATTERY DEPLETION. IT WAS FURTHER REPORTED THAT THE CHRONIC VENTRICULAR LEAD SHOWED HIGH IMPEDANCES AND THRESHOLDS AND REPOSITIONING WAS ATTEMPTED TWO TIMES WITH TWO SEPERATE PROCEDURES WITHOUT SUCCESS. THE DEVICE AND CHRONIC LEAD WERE EXPLANTED AND THE DEVICE WAS REPLACED. DURING THE REPLACEMENT PROCEDURE, A NEW LEAD TO REPLACE THE CHRONIC LEAD WAS ATTEMPTED TO BE IMPLANTED, BUT SHOWED HIGH THRESHOLDS, HIGH IMPEDANCES, T-WAVE OVERSENSING, NO CAPTURE, AND THE HELIX WAS RETRACTED AND WOULDN'T EXTEND, BUT WOULD ABRUPTLY SPRING OUT. THIS LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED SUCCESSFULLY. 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 LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| O| R 5071 IMPLANTABLE PACING LEAD| 5071 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD