BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANTABLE CHF PULSE GENERATOR

    MDR report key: 1871927 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17499
    Date Received
    October 16, 2010
    Report Date
    September 29, 2010
    Product Code
    NIK
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED THAT THE HEADER WAS LOOSE; HOWEVER STILL ATTACHED TO THE CAN. AN X-RAY WAS PERFORMED WHICH INDICATED THAT THE FEED THRU WIRES WERE BROKEN. THE REPORTED CLINICAL OBSERVATIONS WERE A DIRECT RESULT OF THE BROKEN FEED THRU WIRES CAUSED BY A LOOSE HEADER. DUE TO THE BROKEN FEED THRU WIRES, NO THERAPY WAS AVAILABLE FOR THIS PRODUCT WAS THE TIME OF EXPLANT. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE.

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING. UPON COMPLETION OF ANALYSIS THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD RECEIVED A SHOCK. IT WAS FURTHER REPORTED THAT AT THEIR LAST FOLLOW-UP APPOINTMENT THE PHYSICIAN BELIEVED THAT THERE WAS A LOOSE CONNECTION ISSUE OR A RIGHT VENTRICULAR (RV) LEAD FRACTURE AS THERE WAS NOISE ON THE RATE/SENSE PORTION DURING ISOMETRICS IN ADDITION TO OUT OF RANGE IMPEDANCE MEASUREMENTS ON BOTH THE PACING AND SHOCKING PORTIONS. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE ROOT CAUSE WAS UNABLE TO BE DETERMINED DURING TROUBLESHOOTING. A NEW RV LEAD WAS FIRST PLACED AND IMPEDANCES REMAINED OUT OF RANGE. THE CRT-D WAS THEN ALSO REPLACED AND NO FURTHER COMPLICATIONS WERE REPORTED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THIS PRODUCT WAS TO BE RETURNED FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PRODUCT WAS RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE CHF PULSE GENERATOR NIK

    Patients

    Seq Age Sex Outcome Treatment
    1 0185| 4555| N119| 4470