BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1000165971-2016-00724

    MDR report key: 6105895 · Received November 16, 2016

    Report

    Report Number
    1000165971-2016-00724
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 27, 2016
    PMA / PMN Number
    PP980049
    Removal / Correction Number
    Z-0928-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STANDARD FOLLOW-UP ((B)(6) 2016), THE PHYSICIAN OBSERVED SEVERAL LOW CONTINUITY MEASUREMENTS ON BOTH COILS (LESS THAN 200OHMS).

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention