BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2230451 · Received August 15, 2011

    Report

    Report Number
    3004209178-2011-06381
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 18, 2011
    Report Date
    April 1, 2020
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3487A, LOT# J0455012V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 377845, LOT# V261528018, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. AN ADDITIONAL REPORT WILL BE SENT ONCE ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3487A, LOT# J0455012V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 377845, LOT# V261528018, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. IT WAS DETERMINED THAT THE DEVICE WAS NON-ANALYZABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REVISED. THE PATIENT WAS LATER ADMITTED TO THE HOSPITAL WITH AN ELEVATED WHITE BLOOD CELL LEVEL AND PAIN AT THE INS SITE. THERE WAS REDNESS, SWELLING AND PAIN AT THE INS SITE AND AN INFECTION WAS DIAGNOSED ON (B)(6) 2011. THE HEALTH CARE PROVIDER DECIDED TO REMOVE THE ENTIRE SYSTEM WITH THE EXCEPTION OF THE LEAD IN ORDER TO TREAT THE INFECTION. A CULTURE WAS OBTAINED FROM THE DEVICE POCKET, NO ORGANISM WAS CULTURED. THE PATIENT WAS ALSO TREATED WITH IV ANTIBIOTICS AND RECOVERED FROM THE INFECTION WITHOUT SEQUELAE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0455012V| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB005544V| PROGRAMMER: MODEL 37742, LOT# NJD026973N| EXPLANTED:| IMPLANTED:| EXTENSION: MOEDL 37082, LOT# NKB002138N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V261528018| EXPLANTED: