BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2811261 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16354
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    March 29, 2013
    Manufacturer
    MPRI
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.  (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED IN PART ON DEVICE RETURN AND ANALYSIS. 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 ALL INSULATORS WERE BREACHED DUE TO CLAVICLE RIB CRUSH. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL AND PROXIMAL CONDUCTORS (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY WAS MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD) AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM. (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION WAS BREACHED DUE TO CLAVICLE-RIB CRUSH. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND TISSUE ON THE HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE WHICH TRIGGERED THE RV LEAD INTEGRITY ALERT. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED OVERSENSING AND AN APPARENT FRACTURE. THE RV LEAD WAS EXPLANTED AND REPLACED. THE RIGHT ATRIAL (RA) LEAD WAS ALSO RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED AND NOT REPLACED BASED ON MEDICAL JUDGMENT. THE RA LEAD WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE WHICH TRIGGERED THE RV LEAD INTEGRITY ALERT. IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINED OF 'SHARP JABS' IN THE PATIENT'S LOWER CHEST FOR THE WEEK PRIOR TO THE PATIENT'S FOLLOW UP VISIT. THE RV LEAD WAS EXPLANTED AND REPLACED. THE RIGHT ATRIAL (RA) LEAD WAS ALSO RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED AND NOT REPLACED BASED ON MEDICAL JUDGMENT. THE RA LEAD WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE WHICH TRIGGERED THE RV LEAD INTEGRITY ALERT. THE RV LEAD WAS EXPLANTED AND REPLACED. THE RIGHT ATRIAL (RA) LEAD WAS ALSO RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED AND NOT REPLACED BASED ON MEDICAL JUDGMENT. THE RA LEAD WAS ANALYZED AND TESTED OUT OF SPECIFICATION. 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 S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 4196 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB