BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2663016 · Received July 20, 2012

    Report

    Report Number
    3004209178-2012-05882
    Event Type
    Injury
    Date Received
    July 20, 2012
    Report Date
    June 22, 2012
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS, MODEL#: 37714, SERIAL#: (B)(4)) FOUND MEDICAL ADHESIVE OBSTRUCTING BOTH CONNECTOR PORTS. MEDICAL ADHESIVE WAS DETECTED AT THE #2, 7, AND 14 BALSEALS; THIS OBSTRUCTION COULD HAVE HINDERED THE FULL INSERTION OF THE LEAD. DURING ANALYSIS, KNOWN GOOD LEADS WERE FULLY INSERTED INTO BOTH BORES. GOOD, STABLE OUTPUT WAS MEASURED ON ALL ELECTRODE PAIRS THE INS HAD WHEN RECEIVED. IT WAS NOTED THAT THE INS HAD BEEN PROGRAMMED FOR 2 X 8 LEADS TO INCLUDE THE #8 - 15 PORT. THE INS WAS CONNECTED TO KNOWN GOOD LEADS. THE ELECTRODES OF THE LEADS WERE PLACED IN 0.9% SALINE SOLUTION. IMPEDANCES WERE MEASURED WITH AN 8840 PROGRAMMER. THERE WAS GOOD IMPEDANCE ON EVERY ELECTRODE PAIR AND IN THE GROUP MEASUREMENT. ANALYSIS OF THE FIRST LEAD (MODEL#: 3887-45, LOT#: V132668) FOUND NO SIGNIFICANT ANOMALY. THE LEAD WAS RETURNED CUT AND IN TWO SEGMENTS. NO SHORTS BETWEEN CIRCUITS WERE DETECTED. ANALYSIS OF THE SECOND LEAD (MODEL#: 3778-60, SERIAL/LOT#: UNKNOWN) FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE SETSCREW MARKS ON THE CONNECTOR SLEEVE WERE TOO PROXIMAL AND INDICATED THAT THE LEAD HAD NOT BEEN FULLY INSERTED INTO THE INS PORT AT ONE TIME. IN ADDITION, THE OUTER INSULATION WAS CUT/BREACHED 16 CENTIMETERS FROM THE DISTAL END. NO SHORTS BETWEEN CIRCUITS WERE DETECTED. ANALYSIS OF THE ANCHOR (MODEL#: UNKNOWN, SERIAL/LOT#: UNKNOWN) FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_SILICONEANCHOR, LOT# UNKNOWN, PRODUCT TYPE ACCESSORY; PRODUCT ID 3887-45, LOT# V132668, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD; PRODUCT ID 3887-45, LOT# V132668, IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD; PRODUCT ID 3778-60, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE PROGRAMMER, PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION; (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

    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 THE PATIENT'S DEVICE HAD OPEN CIRCUITS IN THE 8-15 SIDE OF THE DEVICE SINCE IMPLANT APPROXIMATELY 2 MONTHS PRIOR TO REPORT. THE PATIENT DID NOT FEEL STIMULATION AT THOSE CONTACTS. IMPEDANCES OF OVER 40,000 OHMS ON 6 OF 8 CONTACTS ON THE 8-15 SIDE WERE REPORTED. THE PATIENT HAD A REVISION THE DAY OF REPORT DUE TO THE ISSUE. DURING THE CASE THE LEAD WAS REPLACED AND THE NEW LEAD WAS TESTED WITH THE MULTI LEAD TRIALING CABLE (MLTC) AND EVERYTHING WAS REPORTED TO BE IN NORMAL RANGE. THE PHYSICIAN REINSERTED MULTIPLE TIMES AND VISUALLY CONFIRMED THAT EVERYTHING SEEMED TO LINE UP PROPERLY. WITH THE LEAD INSERTED INTO THE 0-7 PORT THE IMPEDANCES SHOWED NORMAL, BUT THE PHYSICIAN COULD NOT GET NORMAL READINGS FOR THE 8-15 PORT. A NEW IMPLANTABLE NEUROSTIMULATOR (INS) WAS USED AND ALL IMPEDANCES WERE NORMAL. THERAPY WAS REPORTED AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention