BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2920034 · Received January 17, 2013

    Report

    Report Number
    3006630150-2013-00097
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REVEALED THAT THE PATIENT'S LEFT HAND AND LEFT ARM HAVE PARALYTIC SYMPTOMS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: SC-1110-02 SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Additional Manufacturer Narrative · 1

    SC-1110-02, S/N (B)(4): THE IPG PASSED ALL VISUAL, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS. SC-8216-50, (B)(4): VISUAL INSPECTION REVEALED THAT THE PADDLE LEAD WAS CLEANLY CUT APPROXIMATELY 15 INCHES FROM ONE OF THE PROXIMAL ENDS OF THE PADDLE LEAD. IN ADDITION, ELECTRODE #8 IS DISLODGED AND MISSING FROM THE PADDLE. THE DAMAGE TO THE DEVICE IS CONSISTENT WITH DAMAGES DURING EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE MISSING CONTACT FROM THE PADDLE LEAD WAS REMOVED AND WAS NOT LEFT INSIDE THE PATIENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL WAS RECEIVED THAT THE PHYSICIAN SAID THERE WERE NO PARALYTIC SYMPTOMS. THE PATIENT WAS EXPERIENCING PROCEDURE RELATED PAIN FROM THE PADDLE LEAD IMPLANT THAT RADIATED INTO BOTH ARMS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT IS EXPERIENCING PARALYSIS ON THE LEFT SIDE OF THE BODY. THE PHYSICIAN BELIEVES THE CAUSE IS DUE TO AN ALLERGIC REACTION. IT IS UNKNOWN AT THIS TIME WHAT WAS THE CAUSE OF THE ALLERGIC REACTION. THE PATIENT WILL BE EXPLANTED AT A LATER DATE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT IS EXPERIENCING PARALYSIS ON THE LEFT SIDE OF THE BODY. THE PHYSICIAN BELIEVES THE CAUSE IS DUE TO AN ALLERGIC REACTION. IT IS UNKNOWN AT THIS TIME WHAT WAS THE CAUSE OF THE ALLERGIC REACTION. THE PATIENT WILL BE EXPLANTED AT A LATER DATE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT IS EXPERIENCING PARALYSIS ON THE LEFT SIDE OF THE BODY. THE PHYSICIAN BELIEVES THE CAUSE IS DUE TO AN ALLERGIC REACTION. IT IS UNKNOWN AT THIS TIME WHAT WAS THE CAUSE OF THE ALLERGIC REACTION. THE PATIENT WILL BE EXPLANTED AT A LATER DATE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT IS EXPERIENCING PARALYSIS ON THE LEFT SIDE OF THE BODY. THE PHYSICIAN BELIEVES THE CAUSE IS DUE TO AN ALLERGIC REACTION. IT IS UNKNOWN AT THIS TIME WHAT WAS THE CAUSE OF THE ALLERGIC REACTION. THE PATIENT WILL BE EXPLANTED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26407 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention