BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3123026 · Received May 21, 2013

    Report

    Report Number
    3006630150-2013-01000
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE LEAD PASSED VISUAL AND MECHANICAL TESTS PERFORMED. THE COMPLAINT WAS NOT CONFIRMED. LEAD PASSED ALL CIS TESTING. LEAD EXHIBITS NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN, THE PHYSICIAN REPLACED THE PADDLE LEAD WITH A NEW ONE DUE TO SUSPECTED DEVICE MALFUNCTION. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE LEAD SITE AND POCKET SITE WHEN STIMULATION WAS TURNED ON. X-RAY WAS TAKEN AND THE PHYSICIAN SUSPECTED INTERNAL CRAMPING OR LEAD COILING/BENDING OF THE LEAD BODY FROM THE CONTACTS TO THE IPG. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO A REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE LEAD SITE AND POCKET SITE WHEN STIMULATION WAS TURNED ON. X-RAY WAS TAKEN AND THE PHYSICIAN SUSPECTED INTERNAL CRAMPING OR LEAD COILING/BENDING OF THE LEAD BODY FROM THE CONTACTS TO THE IPG. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO A REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE LEAD SITE AND POCKET SITE WHEN STIMULATION WAS TURNED ON. X-RAY WAS TAKEN AND THE PHYSICIAN SUSPECTED INTERNAL CRAMPING OR LEAD COILING/BENDING OF THE LEAD BODY FROM THE CONTACTS TO THE IPG. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223617 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention