BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESTORE SENSOR

    MDR report key: 2763583 · Received September 27, 2012

    Report

    Report Number
    3004209178-2012-08646
    Event Type
    Death
    Date Received
    September 27, 2012
    Date of Event
    July 24, 2012
    Report Date
    August 30, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, ,SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-41, LOT# N172222, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PATIENT DEATH. THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS BELIEVED THAT DEATH WAS NOT RELATED TO MEDTRONIC DEVICE. PATIENT DEATH OCCURRED WITHIN 30 DAYS OF DEVICE-RELATED PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S PHYSICIAN REPORTED THAT THE PATIENT HAD LEADS REMOVED ON (B)(6) 2012, AND AN INS WAS LEFT IMPLANTED AT THE TIME OF LEAD REMOVAL TO BE USED WITH A FUTURE LEAD IMPLANT. NO ADDITIONAL INFORMATION FROM THE PHYSICIAN REGARDING IMPLANT THAT OCCURRED (B)(6) 2012. THE CORONER THAT PROCESSED THE CASE REPORTED THAT SHE "MAY HAVE SEEN IT MENTIONED THAT THE DEVICE HAD BEEN REMOVED PRIOR TO DEATH AND THAT BECAUSE THE DEVICE WAS NOT NOTED IN THE AUTOPSY REPORT THAT THEY DID NOT REMOVE IT AND WOULD NOT BE AVAILABLE FOR RETURN TO MANUFACTURER."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF AN AUTOPSY REPORT FROM THE MEDICAL EXAMINER. THE CAUSE OF DEATH WAS REPORTED AS ACUTE MULTI-DRUG INTOXICATION WITH OXYCODONE, TRAMADOL, AND DIAZEPAM AND THE MANNER OF DEATH WAS SUICIDE BY INTENTIONAL ORAL MEDICAMENT OVERDOSE. THE REPORT ALSO STATED THAT "RECENT-APPEARING SOMEWHAT PURPLE BUT WELL-HEALED SCARS ARE NOTED, MODERATE IN SIZE, HORIZONTALLY ORIENTED ON EACH SIDE OF THE ABDOMEN AND TWO MODERATELY LARGE VERTICALLY ORIENTED SCARS ON THE LOWER THORACIC AND LUMBAR BACK" WHICH WERE LIKELY THE RESULT OF THE PATIENT'S RECENT DEVICE-RELATED PROCEDURE. NO OTHER DEVICE-RELATED FINDINGS WERE NOTED IN THE AUTOPSY REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Death