BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3013399 · Received March 20, 2013

    Report

    Report Number
    3006630150-2013-00498
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-3138-35, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS PHIII EXTENSION; MODEL # SC-1110-02 SERIAL/LOT #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS INTUBATED AS A MEANS TO PROVIDE RELIEF FOR THE PAIN BEING EXPERIENCED, WHICH WAS DUE TO THE PROCEDURE AND NOT THE DEVICE. THE PATIENT WAS EXPLANTED AND IS NOW RECOVERING AT HOME.

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT ANALYSIS INDICATED THAT THE PADDLE LEAD PASSED PHOTOGRAPHIC TESTING. THE LEAD WAS FOUND TO BE CUT. DAMAGE TO THE DEVICE WAS SIMILAR TO THE TYPICAL EXPLANT PROCEDURE DAMAGE AND WAS NOT CONSIDERED A FAILURE. THE RETURNED PRODUCT ANALYSIS INDICATED THAT THE IPG PASSED ELECTRICAL, PERFORMANCE AND VISUAL TESTS PERFORMED. THE COMPLAINT REGARDING SEVERE PAIN WAS NOT VERIFIED. THE DEVICE PASSED ALL REQUIRED TESTS. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. THE RETURNED PRODUCT ANALYSIS INDICATED THAT THE LEAD EXTENSION PASSED ELECTRICAL, PHOTOGRAPHIC AND VISUAL TESTS PERFORMED. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING AN IMPLANT PROCEDURE FOLLOWING THE INSERTION OF THE PADDLE LEAD THE PATIENT WAS EXPERIENCING SEVERE ABDOMINAL PAIN POST-OPERATIVE AND WAS INTUBATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT SUBSEQUENTLY DEVELOPED A HEMATOMA WHICH THE PHYSICIAN ASSESSED WAS PROBABLY CAUSED BY THE EXPLANT PROCEDURE. THE PATIENT REMAINED IN SEVERE PAIN AND THE HEMATOMA WAS EVACUATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING AN IMPLANT PROCEDURE FOLLOWING THE INSERTION OF THE PADDLE LEAD THE PATIENT WAS EXPERIENCING SEVERE ABDOMINAL PAIN POST-OPERATIVE AND WAS INTUBATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT SUBSEQUENTLY DEVELOPED A HEMATOMA WHICH THE PHYSICIAN ASSESSED WAS PROBABLY CAUSED BY THE EXPLANT PROCEDURE. THE PATIENT REMAINED IN SEVERE PAIN AND THE HEMATOMA WAS EVACUATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING AN IMPLANT PROCEDURE FOLLOWING THE INSERTION OF THE PADDLE LEAD THE PATIENT WAS EXPERIENCING SEVERE ABDOMINAL PAIN POST-OPERATIVE AND WAS INTUBATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT SUBSEQUENTLY DEVELOPED A HEMATOMA WHICH THE PHYSICIAN ASSESSED WAS PROBABLY CAUSED BY THE EXPLANT PROCEDURE. THE PATIENT REMAINED IN SEVERE PAIN AND THE HEMATOMA WAS EVACUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115829 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R