BEUDAMED
    FDA Adverse Event Death Summary report: N

    PISCES-QUAD

    MDR report key: 2992106 · Received March 7, 2013

    Report

    Report Number
    3007566237-2013-00701
    Event Type
    Death
    Date Received
    March 7, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF DEATH WAS UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED CPR AND BASIC LIFE SUPPORT AT THE TIME OF THE CODE AT IMPLANT. THE PATIENT RECEIVED CARDIAC AND BRAIN INJURY TREATMENT WHILE IN THE ICU, BUT PASSED AWAY. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ADVERSE "ANESTHESIA EVENT" DURING THE LEAD PLACEMENT PORTION OF A SPINAL CORD STIMULATOR IMPLANT CASE. IT WAS STATED THE PATIENT HAD A "LOSS OF AIRWAY AND HEART STOPPAGE." ONCE THE PATIENT WAS STABILIZED, THE FOUR LEADS WERE REMOVED. IT WAS REPORTED THE PATIENT WAS "ALIVE, WITH INJURY" AND REMAINED IN THE INTENSIVE CARE UNIT (ICU) AS OF THIS REPORT DATE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97924 PISCES-QUAD STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC NEUROMODULATION 3888-56 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death| H| L| R