BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3031420 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04499
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 13, 2013
    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 37743, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE PROGRAMMER, PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO "BATTERY ISSUES." IT WAS STATED THAT IT WAS NOT CLEAR WHAT THOSE "BATTERY ISSUES" WERE. IT WAS NOTED THAT THE THE EXACT REASON FOR THE REPLACEMENT WAS NOT KNOWN, BUT IT WAS INDICATED THAT IT "WAS NEAR THE END OF THE BATTERY LIFE." A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT'S PHYSICIAN REPORTED THE BATTERY WAS REMOVED DUE TO "END OF SERVICE" AND BECAUSE THE PATIENT EXPERIENCED "RIGHT FLANK PAIN AROUND THE GENERATOR SITE." IT WAS FURTHER NOTED THE FLANK PAIN DEPENDED ON THE PATIENT'S "CURRENT POSITIONING." IT WAS ALSO STATED THE CAUSE OF THE BATTERY DEPLETION WAS "UNKNOWN." THE PATIENT WAS NOTED TO HAVE NOT REQUIRED HOSPITALIZATION FOR THE EVENT AND HAD AN OUTCOME OF "NON-SERIOUS INJURY/ILLNESS." THE DEVICE WAS REPORTEDLY REPROGRAMMED BY THE MANUFACTURE REPRESENTATIVE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134441 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention