BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 7106507 · Received December 11, 2017

    Report

    Report Number
    3006705815-2017-07294
    Event Type
    Injury
    Date Received
    December 11, 2017
    Report Date
    December 11, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. IT WAS REPORTED THAT BOTH OF THE PATIENT¿S LEADS HAD MIGRATED AS CONFIRMED BY X-RAYS. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE SYSTEM ON (B)(6) 2017.

    Description of Event or Problem · 1

    DEVICE 1 OF 2: MFR# 3006705815-2017-07292. IT WAS REPORTED THAT BOTH OF THE PATIENT¿S LEADS HAD MIGRATED AS CONFIRMED BY X-RAYS. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE SYSTEM ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883546 OCTRODE LEAD KIT, 60CM LENGTH 3186 GZB ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000030485

    Patients

    Seq Age Sex Outcome Treatment
    1 Other