BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR MRI

    MDR report key: 4232879 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21086
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    August 23, 2014
    Report Date
    November 1, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED CONCLUSION (B)(4) NO LONGER APPLIES TO THIS EVENT. 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 977A260, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DID NOT HAVE GOOD COVERAGE AND A LEAD REVISION WAS PERFORMED. THE PATIENT RECEIVED GREAT COVERAGE AFTER THE REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT PRIOR TO HAVING THEIR LEAD REPLACED THE DISTAL PART OF THE LEAD TURNED AWAY FROM THE TARGET LOCATION. DUE TO THE LEAD MOVEMENT STIMULATION WASN¿T WORKING CORRECTLY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS A 50% OR GREATER REDUCTION IN SYMPTOMS. THE CAUSE OF THE EVENT WAS NOT DEVICE RELATED AND IT WAS NOTED IT WAS DUE TO "POOR PLACEMENT." THEY REPLACED THE LEADS WITH NEW ONES AND THE PATIENT WAS DOING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713639 RESTORE SENSOR MRI STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention