BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRINSIC

    MDR report key: 1922282 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05911
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    August 31, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND A RANDOM ACCESS MEMORY (RAM) CHIP MEMORY ERROR OCCURRED. A WRITE TO LOCKED RAM POWER ON RESET OCCURRED ON (B)(6) 2010. ADDITIONALLY, THE DEVICE MET 87% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER-ON RESET OF THE DEVICE OCCURRED DURING THE PATIENT'S THERAPEUTIC RADIATION TREATMENT. IT WAS SUBSEQUENTLY REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER-ON RESET OF THE DEVICE OCCURRED DURING THE PATIENT'S THERAPEUTIC RADITION TREATMENT. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD