BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURESCAN

    MDR report key: 3953678 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13451
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-29, LOT # N395647, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 3487A-45, LOT # VA00W6Z, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3487A-45, LOT # VA01C40, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION. ANALYSIS OF THE LEAD, LOT # VA00W6Z, FOUND NO ANOMALY. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS), SERIAL # (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE LEAD, LOT# VA01C40, FOUND THAT THE LEAD BODY¿S OUTER INSULATION HAD BEEN CUT. ANALYSIS OF THE EXTENSION, SERIAL# (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) PLUG, LOT# N395647, FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN INVOLVED IN A FATAL MOTOR VEHICLE ACCIDENT ON (B)(6) 2014. IT WAS STATED THAT THE PATIENT HAD BEEN DRIVING ERRATICALLY AND DRIFTED SLOWLY INTO THE PATH OF AN ONCOMING BUS, WHICH THE PATIENT THEN COLLIDED WITH. IT WAS STATED THAT IT WAS UNKNOWN AS TO WHETHER THERE WERE ANY DRUGS OR ALCOHOL INVOLVED. IT WAS NOTED THAT THE PATIENT¿S SURVIVING FAMILY MEMBER HAD INQUIRED IF ¿THE PATIENT¿S NEUROSTIMULATION SYSTEM COULD HAVE BEEN AT ALL INVOLVED IN THE ACCIDENT.¿ IT WAS FURTHER NOTED THAT THE PATIENT¿S SURVIVING FAMILY MEMBER HAD REQUESTED THAT ¿THE DEVICE BE EXPLANTED FOR RETURN PRODUCT ANALYSIS.¿ IT WAS STATED THAT THE PATIENT HAD LAST MET WITH A MANUFACTURER REPRESENTATIVE OF (B)(6) 2014 FOR POST-OPERATIVE STIMULATOR ADJUSTMENT AND RECHARGER EDUCATION. IT WAS FURTHER STATED THAT THE PATIENT HAD REPORTED ADEQUATE COVERAGE AT THE TIME OF THE MEETING AND ALL IMPEDANCES FOR THE NEUROSTIMULATOR SYSTEM WERE WITHIN NORMAL OPERATING RANGES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF DEATH, ¿AT THE MOMENT,¿ WAS A MOTOR VEHICLE ACCIDENT. IT WAS NOTED THAT THE PATIENT HAD BEEN INSTRUCTED TO TURN THE STIMULATOR OFF WHILE DRIVING. IT WAS STATED THAT THE PATIENT¿S FAMILY WAS BLAMING THE DEVICE FOR HAVING CAUSED THE ACCIDENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATHOLOGIST WAS NOT REMOVING THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN INS, EXTENSION, AND LEADS HAD BEEN RECOVERED FROM THE DECEASED AND WOULD BE RETURNED FOR PRODUCT ANALYSIS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE HAD BEEN RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE PATIENT¿S FAMILY DID NOT WANT THE DEVICE TO UNDERGO DESTRUCTIVE ANALYSIS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN AUTOPSY HAD BEEN DONE AND THE ONLY AVAILABLE INFORMATION STATED THAT THE PATIENT HAD A FENTANYL PATCH ON.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DIED OF MULTIPLE BLUNT IMPACT INJURIES AND CHRONIC PAIN SYNDROME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO HEMORRHAGE ABOUT THE LEAD OR AROUND THE DEVICE ITSELF WHICH APPEARED TO BE INTACT AND NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430457 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97713

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Death