BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN PUMP

    MDR report key: 1870130 · Received October 11, 2010

    Report

    Report Number
    2032227-2010-82914
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 24, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED BY THE CUSTOMER'S ATTORNEY: ATTORNEY ALLEGES ON (B)(6) 2007, PT WAS FOUND UNRESPONSIVE AND UNAROUSABLE ALLEGEDLY AS A RESULT OF FAILURE OF HER MINIMED INSULIN PUMP TO FUNCTION AS INTENDED. THE PT IS ALLEGED TO HAVE HAD A CRITICAL LOW BLOOD GLUCOSE LEVEL AND SUFFERED FROM CEREBRAL EDEMA. IT IS CLAIMED THAT THE PT'S HEALTH HAS BEEN PERMANENTLY ALTERED ALLEGEDLY DUE TO THE FAILURE OF HER MINIMED INSULIN PUMP. SHE ALSO SUBSEQUENTLY UNDERWENT A TRACHEOTOMY AND THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROMY. SHE WAS TREATED AT A LONG TERM REHAB FACILITY THAT SPECIALIZES IN BRAIN INJURY PTS. SHE CURRENTLY RESIDES IN A GROUP HOME WHERE SHE RECEIVES CARE REQUIRED FOR HER ACTIVITIES OF DAILY LIVING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN PUMP INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization