BEUDAMED
    FDA Adverse Event Death Summary report: N

    RS-TENS PLUS

    MDR report key: 1753445 · Received July 7, 2010

    Report

    Report Number
    1644243-2010-00008
    Event Type
    Death
    Date Received
    July 7, 2010
    Date of Event
    March 4, 2010
    Report Date
    June 8, 2010
    Manufacturer
    RS MEDICAL
    Product Code
    GZJ
    PMA / PMN Number
    K050740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS TO BE RETURNED BACK TO RS MEDICAL FOR EVALUATION. CURRENTLY AWAITING THE DEVICE RETURN. RETURNED DEVICE EVALUATION RESULTS WILL BE SUPPLEMENTED WHEN AVAILABLE. PATIENT HAD A ONE MONTH PRESCRIPTION FOR RS-TENS PLUS DATED (B)(6) 2010 FOR TREATMENT OF PATIENT'S KNEE. TENS STIMULATOR WAS USED REPORTEDLY ONE DAY (POST HOSPITAL DISCHARGE AFTER KNEE SURGERY) AND PATIENT WAS REPORTEDLY WEARING THE TENS STIMULATOR AT TIME OF DEATH. RS MEDICAL IS ATTEMPTING TO OBTAIN A DEATH CERTIFICATE. (B)(6). (B)(4).

    Description of Event or Problem · 1

    PATIENT'S WIFE REPORTED THAT THE PATIENT CAME HOME FROM HOSPITAL AFTER SURGERY ON HIS KNEE AND DIED THE NEXT DAY FROM A BLOOD CLOT. THE PATIENT WAS WEARING THE TENS DEVICE AT THE TIME HE DIED. WIFE STATED BY THE TIME THE AMBULANCE ARRIVED HE HAD NO PULSE. WIFE DIDN'T KNOW WHAT KIND OF KNEE SURGERY THE PATIENT HAD. SAYS, SHE FOUND OUT HOW HE DIED FROM THE FUNERAL HOME. THE PATIENT'S WIFE IS NOT ALLEGING THAT THE TENS STIMULATOR CAUSED ANY ADVERSE REACTION, JUST THAT HE WAS WEARING THE TENS STIMULATOR AT THE TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RS-TENS PLUS TRANSCUTANEOUS ELECTRICAL NERVE STIM. GZJ RS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| L