BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1940672 · Received December 22, 2010

    Report

    Report Number
    3006630150-2010-02207
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE EXPLANT PROCEDURE. THE PHYSICIAN DID NOT BELIEVE THE NUMBNESS WAS DEVICE RELATED. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND PADDLE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG AND PADDLE LEAD FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT FOLLOWING THE IMPLANT THE PT DEVELOPED AN INFECTION AT THE POCKET SITE. THE PT'S SYMPTOMS INCLUDED FEVER AND THE WOUND WAS NOT HEALING PROPERLY. THE PT WENT TO THE ER AND WAS TREATED WITH ORAL ANTIBIOTICS. THE PT REPORTED THAT HE WOULD BE EXPLANTED DUE TO THE DEVICE CAUSING NUMBNESS FROM THE WAIST DOWN AND PAIN/ACHING AT THE POCKET SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING THE IMPLANT THE PATIENT DEVELOPED AN INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOMS INCLUDED FEVER AND THE WOUND WAS NOT HEALING PROPERLY. THE PATIENT WENT TO THE ER AND WAS TREATED WITH ORAL ANTIBIOTICS. THE PATIENT REPORTED THAT HE WOULD BE EXPLANTED DUE TO THE DEVICE CAUSING NUMBNESS FROM THE WAIST DOWN AND PAIN/ACHING AT THE POCKET SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM,| MODEL# SC-8216-70| SERIAL# (B)(4)