BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 7873656 · Received September 13, 2018

    Report

    Report Number
    3006630150-2018-60886
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    August 20, 2018
    Report Date
    September 13, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE LEADS WERE DISCARDED BY THE FACILITY. AS THE DEVICES INVOLVED IN THE COMPLAINT HAVE NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A DEVICE ANALYSIS. HOWEVER A REVIEW OF THE COMPLAINT REPORT AND DEVICE HISTORY RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT, THERE IS NO REASON TO SUSPECT A MANUFACTURING DEFECT AS THE SOURCE OF THE REPORTED COMPLAINT. ADDITIONAL SUSPECT DEVICES: REFERENCE NUMBER: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 5042133. REFERENCE NUMBER: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50E, SERIAL: (B)(4), BATCH: 5037885. DEVICES WERE DISCARDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A TRIAL PROCEDURE. TWO LEADS WERE PLACED AND INTRAOPERATIVE TESTING WAS PERFORMED TO CONFIRM BACK COVERAGE. UPON COMPLETION OF THE PROCEDURE, THE PATIENT WAS MOVED TO ANOTHER ROOM IN ORDER TO PERFORM PROGRAMMING. PARESTHESIA COVERAGE OF THE PATIENTS LOWER BACK WAS ATTEMPTED BUT WAS UNSUCCESSFUL. AN X-RAY WAS THEN TAKEN, SHOWING THAT LEAD MIGRATION OF APPROXIMATELY 2-3 VERTEBRAL LEVELS CAUDAD HAD OCCURRED IN BOTH LEADS. IT WAS THEN DECIDED TO PLACE A THIRD LEAD AND ANOTHER X-RAY WAS THEN TAKEN TO DOCUMENT THE FINAL LEAD POSITION. THE PATIENT WAS THEN MOVED BACK TO ANOTHER ROOM TO RE-ATTEMPT PROGRAMMING. PARESTHESIA COVERAGE OF THE PATIENTS LOWER BACK WAS AGAIN UNSUCCESSFUL. ANOTHER X-RAY WAS THEN TAKEN AND SHOWED THAT THE THIRD LEAD HAD ALSO MIGRATED CAUDAD APPROXIMATELY 2 VERTEBRAL LEVELS WHEN COMPARED TO THE PREVIOUS X-RAY. IT WAS THEN DETERMINED TO PULL THE LEADS AND END THE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713394 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5057169 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention