BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2792607 · Received October 16, 2012

    Report

    Report Number
    3004209178-2012-09221
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    September 17, 2012
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BULGE IN HER BACK AND THE HEALTH CARE PROVIDER (HCP) INFORMED HER THAT HER LEADS WERE COMING OUT, WHICH WAS CAUSING THE BULGE. THE PATIENT WAS ALLERGIC TO MORPHINE BUT THE HCP WAS GIVING THE PATIENT MORPHINE. THE PATIENT HAD PROBLEMS WITH SHOCKING IN PAST AND THAT IN THE LAST TWO MONTHS THE SHOCKING AS WELL AS THE BULGE HAD BEEN A PROBLEM. THE CALLER ALLEGED THAT THE PATIENT HAD PSYCHOLOGICAL SYMPTOMS WHICH MIGHT HAVE BEEN CAUSED BY THE STIMULATOR. THE PATIENT WAS IN A MENTAL INSTITUTION IN (B)(6) (DUE TO SUICIDAL THOUGHTS AND POSSIBLY HALLUCINATIONS) AND NEEDED A PHYSICIAN TO COME ASSESS HER BACK/TALK ABOUT RESOLVING ISSUE BECAUSE, THE PATIENT WAS NOT ALLOWED TO LEAVE. THE PATIENT HAD BACK SURGERY, BOTH LEGS SHATTERED, SURGERY ON HER HAND AND FAILING KNEES. THE CALLER STATED THESE AS ANCILLARY INFORMATION AND DID NOT SEEM TO RELATE IT TO THE PATIENT'S DEVICE. ADDITIONAL REPORT WILL BE FILED IF THERE IS UPDATED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R