BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 5677363 · Received May 24, 2016

    Report

    Report Number
    3004209178-2016-10241
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    September 8, 2015
    Report Date
    September 14, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID 3778-45, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID 3708160, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID 3708140, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS) WAS RUBBING UP AGAINST THEIR HIPBONE AND CAUSING THEM PAIN WHICH STARTED SIX WEEKS AGO IN (B)(6). WHEN THE PATIENT WOULD GET OUT OF THE CAR OR WHEN THEY BENT THEY FELT A SUPER SHARP PAIN LIKE A ZING TO THE HIP. IT WAS NOTED THE RIGHT INS WAS BACK ONE INCH FROM THE BONE STRUCTURE. IT WAS NOTED THE PATIENT LOST 20 POUNDS FOLLOWING SURGERY. THERE WERE NO FALLS OR TRAUMAS REPORTED THAT COULD BE RELATED TO THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED HIS OLD IMPLANTABLE NEUROSTIMULATOR PINCHED, A SHARP PAIN, WENT BONKERS, BETWEEN HIS RIB AND HIPBONE WHEN HE WOULD GET IN AND OUT OF A CAR. IT WAS REPORTED THAT DUE TO THE LOCATION OF HIS IMPLANTABLE NEUROSTIMULATOR, IT WAS SURGICALLY RELOCATED TO A LOWER SITE ON HIS BODY FROM HIGHER ON HIS FLANK ON (B)(6) 2016.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAD A REVISION TO MOVE THE IMPLANT SINCE IT WAS RUBBING ON HIS WAISTBAND. THE REPRESENTATIVE STATED SHE THOUGHT IT WAS MOVED TO ANOTHER LOCATION IN THE VICINITY OF THE HIP AND NOT THE ABDOMINAL AREA AND NOTED AN EXTENSION WAS ADDED DURING THE REVISION TO GET MORE LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329838 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 57 YR Required Intervention