BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2018996 · Received March 15, 2011

    Report

    Report Number
    3006630150-2011-00338
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE LEAD REVISION, IT WAS DISCOVERED THAT THERE WAS COILING BETWEEN THE PADDLE LEAD AND THE IPG WHICH LED TO THE FRACTURE OF 5 CONTACTS. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-1110-02 SERIAL # (B)(6). DESCRIPTION: IPG KIT (WITHOUT PULL-THROUGH TUNNELER).

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE LEAD REVEALED THE DEVICE HAD LOST INTEGRITY; THE PADDLE LEAD WAS CUT AND THE PADDLE SIDE WAS NOT RETURNED. THE DAMAGE TO THE DEVICE WAS CONSIDERED AS EXPLANT PROCEDURE DAMAGE AND WAS NOT CONSIDERED A FAILURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE PADDLE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE IPG EXHIBITED NORMAL DEVICE CHARACTERISTICS. WHILE THE IPG EXHIBITED NORMAL DEVICE CHARACTERISTICS, THE SOURCE OF THE COMPLAINT IS LIKELY DUE TO LEAD REGISTRATION SHIFT CAUSED BY THE PATIENT'S FALL. THE LEADS MIGHT HAVE BEEN PULLED, AND THEREFORE, LOST CONTACTS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A NON-DEVICE RELATED FALL, THE PATIENT WAS NOT RECEIVING STIMULATION AND WAS RECEIVING HIGH IMPEDANCE READINGS. THE BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PATIENT AND CONFIRMED THE HIGH IMPEDANCES. X-RAYS REVEALED THAT THE PADDLE LEAD TAILS WERE EXTREMELY TWISTED. THE PHYSICIAN BELIEVES THE PATIENT PLAYS WITH THE IPG AND RECOMMENDED A REVISION. THE BSN FCE RECOMMENDED THE PADDLE LEAD BE REPLACED DUE TO THE HIGH IMPEDANCES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A NON-DEVICE RELATED FALL, THE PATIENT WAS NOT RECEIVING STIMULATION AND WAS RECEIVING HIGH IMPEDANCE READINGS. THE BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PATIENT AND CONFIRMED THE HIGH IMPEDANCES. X-RAYS REVEALED THAT THE PADDLE LEAD TAILS WERE EXTREMELY TWISTED. THE PHYSICIAN BELIEVES THE PATIENT PLAYS WITH THE IPG AND RECOMMENDED A REVISION. THE BSN FCE RECOMMENDED THE PADDLE LEAD BE REPLACED DUE TO THE HIGH IMPEDANCES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A NON-DEVICE RELATED FALL, THE PATIENT WAS NOT RECEIVING STIMULATION AND WAS RECEIVING HIGH IMPEDANCE READINGS. THE BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PATIENT AND CONFIRMED THE HIGH IMPEDANCES. X-RAYS REVEALED THAT THE PADDLE LEAD TAILS WERE EXTREMELY TWISTED. THE PHYSICIAN BELIEVES THE PATIENT PLAYS WITH THE IPG AND RECOMMENDED A REVISION. THE BSN FCE RECOMMENDED THE PADDLE LEAD BE REPLACED DUE TO THE HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention