BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4874680 · Received June 29, 2015

    Report

    Report Number
    3004209178-2015-12397
    Event Type
    Injury
    Date Received
    June 29, 2015
    Report Date
    June 8, 2015
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE PULSE GENERATOR ((B)(4)) FOUND THE BATTERY REDUCED CAPACITY DUE TO OVERDISCHARGE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3888-33, LOT # V621070, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # VA01BCP, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT # VA03DT1, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V974727, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GRADUAL LOSS OF STIMULATION/THERAPEUTIC EFFECT. AS A RESULT OF THE EVEN THERE WAS AN EXPLANT. THERE WAS LESS THAN 50% THERAPY RELIEF, THE LOCATION OF THE ISSUE OR SYMPTOM WAS AT THE LEAD LOCATION. THE LEADS WERE DISCARDED BY THE FACILITY. THE DATE OF EXPLANT WAS (B)(6) 2015, THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418577 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 Required Intervention