BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET EBI BONE HEALING SYSTEM

    MDR report key: 4950476 · Received July 29, 2015

    Report

    Report Number
    0002242816-2015-00077
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    July 2, 2015
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP790002
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRAINDICATIONS FOR THE DEVICE STATE "UNDER CERTAIN CONDITIONS, ELECTROMAGNETIC STIMULATION GENERATED BY A BONE HEALING SYSTEM COULD INHIBIT THE OUTPUT OF SOME DEMAND PACEMAKERS OR IMPLANTABLE DEFIBRILLATORS. THEREFORE, IT IS NOT RECOMMENDED FOR PATIENTS WITH CERTAIN TYPES OF PACEMAKERS OR IMPLANTABLE DEFIBRILLATORS. PATIENTS SHOULD BE CAUTIONED TO AVOID COMING IN CLOSE PROXIMITY TO PACEMAKER OR DEFIBRILLATOR WEARERS DURING STIMULATION TREATMENT." WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTS FITTING THE PATIENT WITH THE BONE GROWTH STIMULATOR ON (B)(6) 2015, HE LATER RECEIVED A CALL FROM THE PATIENT STATING THAT HE HAD READ THROUGH SOME OF THE PAMPHLETS AND HE READ THAT THIS DEVICE IS NOT TO BE USED FOR PATIENTS WITH A PACEMAKER. THE SALES ASSOCIATE ASKED THE PATIENT TO DISCONTINUE USING THE DEVICE UNTIL HE CONSULTED HIS CARDIOLOGIST. AT THE TIME OF THE PHONE CALL THE PATIENT DID NOT REPORT EXPERIENCING ANY NEGATIVE REACTIONS TO THE DEVICE. THE SALES ASSOCIATE ASKED THE PATIENT TO CALL HIM NEXT WEEK AFTER SPEAKING WITH HIS DOCTOR. THE SALES ASSOCIATE REPORTS HE SPOKE TO THE PATIENT ON TUESDAY (B)(6) 2015, AT THIS TIME THE PATIENT ALLEGES "THAT THE DEVICE HAD CAUSED HIS PACEMAKER TO MALFUNCTION AND THAT HE EXPERIENCED AN ELECTRIC CURRENT ALL OVER HIS BODY DUE TO USE OF THE DEVICE. HE ALSO STATED THAT HIS DOCTOR FORGOT HE HAD A PACEMAKER WHEN HE PRESCRIBED THE BONE SIMULATOR, HE ALSO MADE STATEMENTS THEY HE MAY NEED TO HAVE HIS PACEMAKER REPLACED NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494211 BIOMET EBI BONE HEALING SYSTEM NON-INVASIVE BONE GROWTH STIMULATOR LOF EBI, LLC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other