BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3407066 · Received October 11, 2013

    Report

    Report Number
    3004209178-2013-19010
    Event Type
    Injury
    Date Received
    October 11, 2013
    Report Date
    September 24, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377860 LOT# V020880, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 377860 LOT# V019919, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (IPG 37713 RESTORE, SERIAL #(B)(4)) FOUND ITS BATTERY CAPACITY REDUCED DUE TO OVERDISCHARGE. THERE WAS FOREIGN MATERIAL UNDER CONNECTOR MODULE COVER AND IN CONNECTOR PORTS. ACCESS HOLE ADHESIVE WAS LOOSE. BOTH GROMMETS WERE LOOSE. THERE WAS A PUNCH-OUT HOLE IN THE #8 GROMMET. THE SHIELD/CAN WAS SCRATCHED. THERE HAD BEEN ONLY ONE OVERDISCHARGE AND THE BATTERY HAD BEEN RECOVERED IN THE FIELD. ANALYSIS OF THE LEAD (LEAD 377860 OCTAD 1X8) FOUND ALL OF ITS BODY CONDUCTORS WERE BROKEN AT TITAN ANCHOR SITE 24.5 CM FROM DISTAL END. LEAD'S OUTER INSULATION WAS MELTED, CAUTERY SUSPECTED. FUNCTIONAL TEST SHOWED OPEN CIRCUITS. ANALYSIS OF THE LEAD (LEAD 377860 OCTAD 1X8) FOUND ALL OF ITS BODY CONDUCTORS BROKEN NEAR TITAN ANCHOR SITE 17.8 CM FROM DISTAL END. TITAN ANCHOR SITE WAS 19.3 CM FROM THE DISTAL END. LEAD'S OUTER INSULATION WAS MELTED, CAUTERY SUSPECTED. ELECTRODES #5 AND #7 ON THE LEAD'S DISTAL END HAD BEEN CRUSHED. FUNCTIONAL TEST SHOWED OPEN CIRCUITS.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COMMUNICATION PROBLEM AND THE PATIENT HAD BEEN WORKING ON RECHARGING FOR THE PRIOR 2-3 DAYS. IT WAS NOTED THAT THE PATIENT LAST RECHARGED 3-4 WEEKS AGO AND THAT SHE TYPICALLY KEPT STIMULATION AT A VERY LOW LEVEL. IT WAS NOTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS FURTHER REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. IT WAS NOTED THAT THE PATIENT WAS SEEING POOR COMMUNICATION UPON INTERROGATION WITH THE PATIENT PROGRAMMER. IT WAS LATER REPORTED THAT EOL (END OF LIFE) WAS REACHED SO THE SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522432 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 00049 YR Required Intervention