BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3251610 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12393
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 20, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-29, LOT # N143115, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 3 778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708160, SERIAL # (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID NE U_SILICONE ANCHOR, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE STIMULATOR, SERIAL (B)(4), FOUND THE BATTERY HAD A REDUCED CAPACITY DUE TO OVERDISCHARGE. THERE WERE NO SIGNIFICANT ANOMALIES. ANALYSIS OF THE LEAD, LOT #V119687012, FOUND THE PROXIMAL END CONDUCTOR HAD A SHORT BETWEEN CIRCUITS DUE TO OVERSTRESS AND DAMAGE. THE SHORTING WAS OBSERVED AT THE #13 CONTACT AND THE #15 CONDUCTOR ON THE CONNECTOR END. THE EPOXY WAS BROKEN AT THE PROXIMAL SIDE OF THE #13 CONTACT. THE STYLET COIL WAS CRUSHED IN TWO PLACES FROM THE DISTAL END. THERE WERE COSMETIC AND BREACHED CUTS. THERE WERE NO SIGNIFICANT ANOMALIES. ANALYSIS OF THE EXTENSION, SERIAL (B)(4), FOUND THE BODY CONDUCTOR BROKEN DUE TO OVERSTRESS AND DAMAGE. THE CONDUCTOR WAS ALSO PERFORATED THROUGH THE OUTER INSULATION. THE #14 CIRCUIT WAS OPEN. THERE WERE COSMETIC AND BREACHED CUTS. THERE WERE NO SIGNIFICANT ANOMALIES. ANALYSIS OF THE PLUG, LOT #N143224, FOUND NO ANOMALY. ANALYSIS OF THE UNKNOWN SILICONE ANCHOR FOUND NO ANOMALY.

    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 IMPLANTABLE NEUROSTIMULATOR WAS EXPLANTED BECAUSE IT WAS ¿NO LONGER WORKING.¿ IT WAS LATER REPORTED THAT THE PATIENT HAD REQUESTED THAT THE STIMULATOR BE REMOVED ON (B)(6) 2013. THE PATIENT STATED THAT IT WAS NO LONGER HELPING HER PAIN AND THE STIMULATOR HAD MOVED IN THE POCKET. IT WAS NOTED THAT ON (B)(6) 2013 THE STAPLES WERE REMOVED POST-EXPLANT AND THE PATIENT WAS RECOVERING WELL. IT WAS LATER REPORTED THAT THE DATE OF EXPLANT WAS (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353637 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 00051 YR Required Intervention