BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3130945 · Received May 24, 2013

    Report

    Report Number
    3006630150-2013-01050
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    SC-2218-50, SN (B)(4): DEVICE EVALUATION INDICATED THAT THE LEAD PASSED MECHANICAL TEST PERFORMED. THE COMPLAINT HAS BEEN CONFIRMED. HIGH RESISTANCE READINGS WERE REGISTERED AT CONTACTS 4, 5 AND 7. VISUAL AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION IS FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE. SC-2218-50, SN (B)(4): A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD HAD 2 CONTACTS THAT WERE SHOWING HIGH IMPEDANCE AND WERE NOT FUNCTIONING. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN, THE LEAD WAS REPLACED WITH A NEW ONE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD HAD 2 CONTACTS THAT WERE SHOWING HIGH IMPEDANCE AND WERE NOT FUNCTIONING. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN, THE LEAD WAS REPLACED WITH A NEW ONE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231489 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1