BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3948305 · Received July 21, 2014

    Report

    Report Number
    3006630150-2014-01636
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DATABASE ANALYSIS REVEALED THE BATTERY DISCHARGE AND CHARGE PROFILE WERE OBSERVED AND REVEALED NO ANOMALIES. THE DEVICE APPEARED TO BE WORKING AS EXPECTED. THE PATIENT WAS INFORMED OF THE RESULT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN AN EXTENSION WAS ADDED. THE PATIENT WAS STILL SWOLLEN POSTOPERATIVELY AND WAS NOT ABLE TO CHARGE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING AND HAD SWELLING AT THE IPG SITE. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING AND HAD SWELLING AT THE IPG SITE. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING AND HAD SWELLING AT THE IPG SITE. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425963 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention