BEUDAMED
    FDA Adverse Event Other Summary report: N

    RS-OA KNEE SYSTEM

    MDR report key: 2018677 · Received March 4, 2011

    Report

    Report Number
    1644243-2011-00006
    Event Type
    Other
    Date Received
    March 4, 2011
    Date of Event
    December 1, 2011
    Report Date
    February 3, 2011
    Manufacturer
    RS MEDICAL
    Product Code
    NYN
    PMA / PMN Number
    K062325
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RS-OA KNEE STIMULATOR HAS BEEN RETURNED AND MET ALL APPLICABLE QUALITY ASSURANCE CRITERIA AND SPECIFICATIONS. RS-OA OPERATION MANUAL CONTRAINDICATIONS SPECIFY "DO NOT USE THE DEVICE IF YOU ARE A CARDIAC DEMAND PACEMAKER." PRESCRIBING PHYSICIAN IS (B)(6).

    Description of Event or Problem · 1

    PT CLAIMS USE OF THE RS-OA KNEE SYSTEM STIMULATOR INTERFERED WITH IMPLANTED CARDIAC PACEMAKER RESULTING IN TRANSIENT HEART RATE CHANGES. PT WAS USING THE STIMULATOR FOR THEIR INITIAL TREATMENT BUT SUSPENDED THE TREATMENT AFTER A FEW MINUTES WHEN HEART RATE CHANGES WAS OBSERVED. PT SAID THE IMPLANTED PACEMAKER WAS AFFECTED BY THE KNEE STIMULATION TREATMENT. PT DID NOT SUFFER ANY FURTHER EFFECTS OR ANY INJURY. PT CONSULTED WITH HIS CARDIOLOGIST, DID NOT USE THE STIMULATOR FURTHER AND RETURNED THE KNEE STIMULATOR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RS-OA KNEE SYSTEM TRANSCUTANEOUS KNEE NERVE/MUSCLE STIM. NYN RS MEDICAL RS-OA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other OA KNEE BRACE