BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESTORE ULTRA

    MDR report key: 5828969 · Received July 28, 2016

    Report

    Report Number
    3004209178-2016-15086
    Event Type
    Death
    Date Received
    July 28, 2016
    Date of Event
    June 27, 2016
    Report Date
    August 30, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THE DEVICE NEVER WORKED SINCE IMPLANT AND IT CAUSED THE PATIENT MORE PAIN THAN IT HELPED. AS A RESULT THE DEVICE HADN'T BEEN USED IN YEARS. IT WAS FURTHER REPORTED THE PATIENT DIED LAST WEEK AND THE FUNERAL HOME MANAGER WAS LOOKING FOR GUIDANCE TO REMOVE THE STIMULATOR. ACCORDING TO THE FUNERAL HOME MANAGER THE PATIENT'S FAMILY CLAIMED THE STIMULATOR NEVER WORKED AND CAUSED THE PATIENT DEATH, SO THEY WANTED TO HAVE IT REMOVED AND RETURNED TO THEM. THE FUNERAL HOME DID NOT HAVE A CAUSE OF DEATH LISTED BUT WERE CALLED TO RETRIEVE THE PATIENT'S BODY ON (B)(6) 2016 SO THAT WAS MOST LIKELY THE DATE OF THE DEATH. THE DOCTOR WAS CONTACTED AND WAS UNAWARE OF THE CAUSE OF DEATH. THE LAST TIME THE PATIENT WAS SEEN IN THEIR OFFICE WAS IN 2009. RELEVANT MEDICAL HISTORY INCLUDES INTERCOSTAL NEURALGIA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER NOTED THAT THE PATIENT DID NOT EXPIRE AT THAT FACILITY. H AND P (HISTORY AND PHYSICAL) AND D/S (DISCHARGE SUMMARY) OF MOST RECENT ADMISSION NOTED: ADMIT DATE - (B)(6) 2016. CHIEF COMPLAINT: AMS (ALTERED MENTAL STATUS). PATIENT IS A (B)(6) FEMALE WITH A HISTORY OF POLYPHARMACY AND LEGALLY BLIND WHO WAS BROUGHT TO THE ED (EMERGENCY DEPARTMENT) AFTER BEING FOUND BY DHR IN HER HOME NAKED, DISORIENTED, AND SOILED LYING ON HER COUCH. THE PATIENT WAS LAST ADMITTED LAST MONTH AND LEFT AMA (AGAINST MEDICAL ADVICE). ON ARRIVAL TO THE ED PULSE WAS 118 BP 166/92 AND RESPIRATIONS 30. WBC - 21.8 SEG% - 76, AND LYMPH % - 19. SODIUM - 148, CO2 - 20, BUN - 28, CALCIUM - 10.3, GLUCOSE - 158, ALK PHOS - 538, AST - 67 AND ALT - 57. URINE NEGATIVE FOR INFECTION. CPK - 761 AND MYOGLOBIN - 354. CT OF THE BRAIN NEGATIVE FOR ACUTE PROCESS. CHEST X-RAY READ AS PNEUMONIA BY ER. URINE DRUG SCREEN POSITIVE FOR TRICYCLICS. IN THE ED SHE RECEIVED ZOSYN, CIPRO, AND VANCOMYCIN. THE PATIENT WAS ADMITTED TO THE HOSPITALIST SERVICES. ASSESSMENT/PLAN: ENCEPHALOPATHY - HISTORY OF MULTIPLE ADMISSIONS FOR POLYPHARMACY AND OVERDOSES. PATIENT SOMNOLENT, DISORIENTED, SLOW TO RESPOND ON EXAM. CHEST X-RAY READ AS PNEUMONIA IN ER, PT ON ANTIBIOTIC COVERAGE. LABS CONSISTENT WITH DEHYDRATION. CONTINUE IV FLUID HYDRATION. MILD RHABDOMYOLYIS - CPK - 761 AND MYOGLOBIN 354 ON ADMISSION. HISTORY SEIZURE ACTIVITY - STABLE. FIBROMYALGIA/CHRONIC PAIN. HISTORY OF UNSPECIFIED MENTAL ILLNESS. DISCHARGE DISPOSITION - PATIENT NOT SAFE TO RETURN TO PREVIOUS SETTING. DVT (DEEP VEIN THROMBOSIS)/GI PROPHYLAXIS - LOVENOX/PROTONIX. FINAL DIAGNOSIS - ENCEPHALOPATHY, TOXIC; DEHYDRATION; RHABDOMYOLYSIS, MILD; SEIZURE HISTORY; FIBROMYALGIA/CHRONIC PAIN; LEGALLY BLIND; POLYPHARMACY; OPIATIC ABUSE; MULTIPLE DRUG OVERDOSES HISTORY; ANEMIA; SKIN CANCER. DISCHARGE DATE - (B)(6) 2016. HOSPITAL COURSE: (B)(6) FEMALE WITH HISTORY OF POLYPHARMACY LEGALLY BLIND WITH MULTIPLE PREVIOUS ADMISSIONS IN THE PAST WHO WAS BROUGHT TO ED AFTER BEING FOUND BY DHR HER HOME NAKED, DISORIENTED, AND SO ON HER COUCH. SHE WAS DIAGNOSED AND TREATED FOR DEHYDRATION, RHABDOMYOLYSIS WITH IV FLUIDS. SHE WAS AFEBRILE AND NO EVIDENCE OF ANY INFECTIOUS PROCESS UNCOVERED. PATIENT DID HAVE A MENTION OF DIARRHEA HOWEVER NO DIARRHEA DURING ADMISSION. STOOL STUDIES WERE OBTAINED AND WERE NEGATIVE FOR BLOOD CELLS, CULTURE NEGATIVE, STOOL C DIFF NEGATIVE. BLOOD CULTURES NEGATIVE TO DATE X 2. PATIENT DID NOT HAVE ELECTRICITY IN HER HOME WHICH LIKELY CONTRIBUTED TO HER DEHYDRATION. HER ELECTRICITY WAS TURNED ON TODAY. CT BRAIN WAS NEGATIVE FOR ACUTE INTRACRANIAL PROCESS, POSITIVE FOR OLD INFARCTS AND CHRONIC ATROPHY WITH SMALL VESSEL CHANGES. HER ALTERED MENTAL STATUS IMPROVED WITH HYDRATION AND SHE IS CURRENTLY AT BASELINE. SHE IS IN STABLE CONDITION. DECREASED ZOLPIDEM AND CLONAZEPAM DOSE INN HALF DUE TO POLYPHARMACY AND NUMEROUS ADMISSIONS WITH ALTERED MENTAL STATUS/OVERDOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482201 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| H| R