BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3193379 · Received June 27, 2013

    Report

    Report Number
    3006630150-2013-01313
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    November 26, 2011
    Report Date
    November 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT AND WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS KEPT 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION CANNOT BE OBTAINED REGARDING THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE AND THE IPG WOULD NOT HOLD A CHARGE. THE PATIENT HAD A NON-DEVICE RELATED SURGERY WHEREIN AN ELECTROCAUTERY WAS USED. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE AND THE IPG WOULD NOT HOLD A CHARGE. THE PATIENT HAD A NON-DEVICE RELATED SURGERY WHEREIN AN ELECTROCAUTERY WAS USED. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE AND THE IPG WOULD NOT HOLD A CHARGE. THE PATIENT HAD A NON-DEVICE RELATED SURGERY WHEREIN AN ELECTROCAUTERY WAS USED. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291905 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention