BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RS-2M MUSCLE STIMULATOR

    MDR report key: 2002343 · Received February 15, 2011

    Report

    Report Number
    1644243-2011-00003
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    May 29, 2010
    Report Date
    January 21, 2011
    Manufacturer
    RS MEDICAL
    Product Code
    IPF
    PMA / PMN Number
    K021763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RS-2M STIMULATOR HAS NOT YET BEEN RETURNED FOR ANALYSIS. BOTH THE RS-2M MUSCLE STIMULATOR AND RS-TENS PLUS WERE PRESCRIBED FOR USE ON THE LOWER LEFT BACK AREA. SITE OF PACEMAKER IMPLANT IS NOT KNOWN. PATIENT'S WIFE SAID SHE BELIEVED THE PACEMAKER RESET/PATIENT'S REPORTED ATRIAL FIBRILLATION WERE DUE TO USE OF THE STIMULATOR(S). PHYSICIAN'S OPINION WAS NOT OBTAINED. RS-2M OPERATION MANUAL CONTRAINDICATES DEVICE USE IN PRESENCE OF IMPLANTED PACEMAKERS STATING "DO NOT USE THE DEVICE IF YOU USE A CARDIAC DEMAND PACEMAKER." THE OPERATION MANUAL ALSO CONTRAINDICATES DEVICE USE IN CANCER PATIENTS STATING "DO NOT USE THE DEVICE IF YOU HAVE ANY FORM OF CANCER." WE ARE UNABLE TO CONFIRM ANY CAUSE AND EFFECT FOR THE REPORTED EVENT AND A MUSCLE STIMULATION TREATMENT IN THIS CASE. PRESCRIBING PHYSICIAN IS (B)(6), M.D., (B)(6). MDR FILED ON (B)(4) 2011.

    Description of Event or Problem · 1

    PATIENT'S WIFE STATED THAT PATIENT WAS USING BOTH THE RS-2M MUSCLE STIMULATOR AND RS-TENS PLUS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR WITH ASSOCIATED PATIENT CABLES AND 2" ROUND CUTANEOUS ELECTRODES. PATIENT NEEDED TO BE RUSHED TO THE HOSPITAL EMERGENCY ROOM BECAUSE SOMETHING HAPPENED TO THE PATIENT'S IMPLANTED PACEMAKER AND IT HAD TO BE RESET. PATIENT'S WIFE CALLED ON (B)(6) 2010 TO SAY THE PATIENT WANTED TO RETURN HIS STIMULATORS BECAUSE HE CAN'T USE THEM DUE TO CONCOMITANT CANCER AND AN IMPLANTED PACEMAKER. PATIENT'S WIFE CALLED ON (B)(6) 2011 TO COMPLAIN ABOUT STILL RECEIVING CONDUCTIVE GARMENT ELECTRODE PADS BUT PATIENT CAN'T USE DUE TO IMPLANTED PACEMAKER AND CANCER. PATIENT'S WIFE THEN EXPLAINED THE (B)(6) 2010 EMERGENCY ROOM VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RS-2M MUSCLE STIMULATOR TRANSCUTANEOUS ELECTRICAL MUSCLE STIM IPF RS MEDICAL RS-2M

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention STIMULATOR (SN (B)(4)) AND| RS-LFS (SN (B)(4)) WERE PRESCRIBED| PATIENT| RS-LFS LUMBAR BRACE NOT USED, WAS TOO SMALL FOR| RS-LBL LOW BACK CONDUCTIVE GARMENT (SN (B)(4))| PRESCRIBED| RS-TENS PLUS TRANSCUTANEOUS ELECTRICAL NERVE| RS-2M AND