BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2738111 · Received September 10, 2012

    Report

    Report Number
    3004209178-2012-07951
    Event Type
    Injury
    Date Received
    September 10, 2012
    Report Date
    August 20, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377660 LOT#: V013969 SERIAL#: IMPLANTED: 2007 (B)(6), EXPLANTED: PRODUCT TYPE: LEAD PRODUCT ID: 37752 LOT#: SERIAL#: (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: PRODUCT TYPE: RECHARGER PRODUCT ID: 37742 LOT#: SERIAL#: (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S INS WAS REPLACED ONE MONTH PREVIOUS, IN (B)(6) 2012. THE PATIENT'S LEAD WAS LEFT IN. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE REASON FOR DEVICE REPLACEMENT WAS THAT THE PATIENT FAILED TO CHARGE THE BATTERY AND DESTROYED IT. DEPRESSION WAS BLAMED AS THE CAUSE. IT WAS ALSO BELIEVED THAT THE SUB-PAR STIMULATION DUE TO RIB STIMULATION FROM AN ORIGINALLY HIGH LEAD PLACEMENT WAS THE CAUSE. SEE MFR REPORT # 3004209178-2012-08217 FOR INFORMATION ON HIGH LEAD PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention