BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2221046 · Received August 23, 2011

    Report

    Report Number
    3006630150-2011-01330
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 31, 2011
    Report Date
    July 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S WOUND FOLLOWING THE EXPLANT PROCEDURE ISN'T HEALING PROPERLY. THE PATIENT WAS PUT ON A WOUND VACUUM AND IS DOING WELL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-8216-50, (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD WITH PLATNALOCK TECHNOLOGY - 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR EVALUATION AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOMS CONSISTED OF HEADACHES, LACK OF ENERGY AND SWEAT. THE PHYSICIAN PLACED THE PATIENT ON IV ANTIBIOTICS AND BELIEVES THAT A PRE-EXISTING CONDITION OF OBESITY COULD HAVE CONTRIBUTED TO THE INFECTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOMS CONSISTED OF HEADACHES, LACK OF ENERGY AND SWEAT. THE PHYSICIAN PLACED THE PATIENT ON IV ANTIBIOTICS AND BELIEVES THAT A PRE-EXISTING CONDITION OF OBESITY COULD HAVE CONTRIBUTED TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R