BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT

    MDR report key: 2901835 · Received January 8, 2013

    Report

    Report Number
    2649622-2013-00018
    Event Type
    Death
    Date Received
    January 8, 2013
    Date of Event
    December 17, 2012
    Report Date
    July 5, 2017
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN WHO STATED, "THE LEAD WAS NOT WORKING. THERE WAS A GRADUAL CHANGE IN [THE PATIENT'S] R-WAVES FROM FIVES [MILLIVOLTS (MV)] DOWN TO THE TWOS [MV], THAT IS WHY THE LEAD NEEDED TO BE REMOVED."(B)(4). CONCOMITANT DEVICE: 4568-53 IMPLANTABLE PACING LEAD, (B)(6) 2000.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT DIED DURING LASER LEAD EXTRACTION OF THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD HAD A TREND SHOWING "R WAVES HAD BEEN STABLE IN THIS RANGE" OF 2.0 TO 3.0 MILLIVOLTS; THERE WAS "[N]O UNDERSENSING NOTED." IT WAS FURTHER REPORTED THERE WERE "[S]TABLE IMPEDANCES ON THE PACE/SENSE [PORTION] AS WELL AS ON [THE] COILS" OF THE RV LEAD. THE PATIENT'S CAUSE OF DEATH PER THE CERTIFICATE OF DEATH WAS "COMPLICATIONS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD EXTRACTION WITH PERFORATION OF SUPERIOR VENA CAVA, IN A PERSON REQUIRING GENERATOR REPLACEMENT FOR THE TREATMENT OF CATECHOLAMINERGIC POLYMORPHIC VENTRICULAR TACHYCARDIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9139 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Death| H| L| R D154ATG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR