BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SQ-RX PULSE GENERATOR

    MDR report key: 2940739 · Received January 29, 2013

    Report

    Report Number
    3009448963-2013-00008
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    CAMERON HEALTH, INC.
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY CAMERON HEALTH'S QUALITY LABORATORY. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    CAMERON HEALTH RECEIVED INFORMATION THAT DURING A REGULARLY SCHEDULED FOLLOW-UP VISIT, TWENTY (20) DAYS AFTER IMPLANT, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE PATIENT WAS SENT HOME AND ASKED TO RETURN FOUR (4) DAYS LATER TO ATTEMPT A CONNECTION WITH ANOTHER PROGRAMMER. DURING THE SECOND VISIT, THE INTERROGATION ATTEMPT WAS NOT SUCCESSFUL AND IT WAS FURTHER REPORTED THAT BEEPING TONES WERE EMITTING FROM THE DEVICE. THE PATIENT WAS REQUIRED TO REMAIN IN THE HOSPITAL OR WEAR A LIFE VEST UNTIL EXPLANT COULD BE SCHEDULED. THE DEVICE WAS EXPLANTED NINE (9) DAYS AFTER THE SECOND INTERROGATION ATTEMPT. IT WAS REPORTED THAT THE DEVICE DID NOT EMIT TONES AT THE TIME OF EXPLANT. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EXPLANT. THE DEVICE WILL BE RETURNED TO CAMERON HEALTH FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38876 SQ-RX PULSE GENERATOR DEFIBRILLATOR LWS CAMERON HEALTH, INC. 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R