BEUDAMED
    FDA Adverse Event Death Summary report: N

    RS-TENS PLUS

    MDR report key: 1335806 · Received January 29, 2009

    Report

    Report Number
    1644243-2009-00002
    Event Type
    Death
    Date Received
    January 29, 2009
    Report Date
    January 29, 2009
    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

    THE DEVICE LABELING WAS SILENT RELATIVE TO DEVICE USE IN CANCER PATIENTS. THE COMPANY GENERALLY DOES NOT SUPPORT DEVICE USE IN CANCER PATIENTS OR PATIENTS WITH KNOWN TUMOR ACTIVITY WHICH THE SALES REPRESENTATIVE REFLECTED. THE SAFETY OF TENS DEVICES FOR PATIENTS WITH CANCER IS UNK AND THE CURRENT DEVICE LABELING REFLECTS THAT WARNING. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE RELATEDNESS OF TENS FOR TREATMENT OF CERVICAL AND LUMBAR STRAINS WITH THE DEVELOPMENT OF A NEW PELVIC TUMOR IN A PATIENT WITH PRE-EXISTING CANCER (LUNG AND PELVIC TUMORS) CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    PT'S WIFE CALLED WITH A GENERAL QUESTION AFTER HER HUSBAND EXPIRED FROM CANCER. SHE ASKED IF THE TENS DEVICE IS SAFE TO USE WITH SOMEONE WHO WAS ONE MONTH POST TREATMENT FOR PELVIC AND LUNG CANCER TUMORS AND WILL IT BE SAFE IF THE PERSON HAS MORE TUMORS AND IS IN RADIATION TREATMENT TO USE THE DEVICE. COMPANY'S SALES REPRESENTATIVE TOLD THE PHYSICIAN SHE DID NOT THINK THE DEVICE SHOULD BE USED GIVEN THE RECENT CANCER TREATMENTS. THE ATTENDING PHYSICIAN SAID THERE WERE NO FACTS THAT CANCER PATIENTS SHOULD NOT USE THE DEVICE. THERE WAS QUESTION WHETHER THE ELECTRICAL TREATMENT COULD PROVOKE GROWTH OF CANCER CELLS. PT USED THE TENS DEVICE 2-3 TIMES A DAY FOR A MONTH FOR A CERVICAL STRAIN AND LUMBAR STRAIN BUT DID NOT GET MUCH RELIEF. WITHIN 5 WEEKS A NEW PELVIC TUMOR DEVELOPED. THE PT EXPIRED IN 2008. THE PT'S WIFE STATED SHE KNOWS THE DEVICE DID NOT CAUSE HER HUSBAND'S DEATH, BUT WAS QUESTIONING THE PHYSICIAN'S JUDGEMENT AND MANAGEMENT OF THE CARE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RS-TENS PLUS TENS NERVE STIMULATOR GZJ RS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death RS-LFS LUMBAR BRACE