BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE EXTERNAL NEUROSTIMULATOR

    MDR report key: 3902327 · Received June 30, 2014

    Report

    Report Number
    3007566237-2014-01819
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 11, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT# VA0HZ22, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# VA0J6LR, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (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

    DEVICE EVALUATION: ANALYSIS OF BOTH RETURNED LEADS (LOT NUMBERS VA0HZ22 AND VA0J6JR) FOUND THAT ¿IMPRESSIONS FROM OVER-TIGHTENING OF THE DEPTH STOP WERE OBSERVED ON THE OUTER INSULATION OF BOTH RETURNED LEADS, ABOUT 3 CM FROM THE PROXIMAL END.¿ ANALYSIS OF BOTH STYLETS FOUND THAT ¿IMPRESSIONS WERE ALSO OBSERVED ON THE PARYLENE COATING OF THE TUNGSTEN STYLET UNDERNEATH.¿

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8870BBR01, SERIAL # (B)(4), PRODUCT TYPE SOFTWARE. (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 DURING THE IMPLANT PROCEDURE THE PATIENT EXPERIENCED ¿NO EFFECT FOR THE SYMPTOM¿ AND ¿NO SIDE EFFECT.¿ IT WAS STATED THAT WHEN THE PATIENT¿S LEADS WERE TESTED WITH AN EXTERNAL NEUROSTIMULATOR (ENS) THAT IMPEDANCES OF ¿LESS THAN 250¿ OHMS WERE FOUND. IT WAS NOTED THE OPERATING PHYSICIAN ¿SUSPECTED ELECTRODE CONTACT OF THE LEADS WERE SHORTED OUT¿ AND USED TWO DIFFERENT LEADS TO COMPLETE THE SURGERY. IT WAS REPORTED THE PATIENT WAS ¿GOOD¿ FOLLOWING THE PROCEDURE. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PHYSICIAN SUSPECTED A ¿PROGRAM ERROR IN THE LATEST 8870 PROGRAMMER CARD HE WAS USING.¿ THE PHYSICIAN INDICATED THAT DURING THE TWO MONTHS PRIOR TO FOLLOW-UP, HE HAD EXPERIENCED FIVE CASES WHERE THE PHYSICIAN PROGRAMMER SHOWED ¿PART OR ALL ELECTRONS WERE SHORT¿ DURING IMPEDANCE TESTING. WHEN THE LEAD WAS REMOVED FROM THE PATIENT AND PLACED IN SALT WATER, THE PHYSICIAN PROGRAMMER INDICATED THAT ¿NO PROBLEMS¿ WERE FOUND DURING IMPEDANCE TESTING. FURTHER TESTING OF THE LEAD WITH A PHYSICIAN PROGRAMMER WHILE THE LEAD WAS NOT IN A SALINE SOLUTION OR WHEN TESTED DIRECTLY WITH AN OHM METER WAS REPORTED TO HAVE REVEALED ¿THE LEAD WAS FINE¿ AND THAT THERE WAS ¿NO SHORT AT ALL.¿ PLEASE SEE MANUFACTURER REPORT NUMBERS 6000153-2014-00021, 3007566237-2014-01015, 3007566237-2014-01016, AND 3007566237-2014-01584 FOR INFORMATION REGARDING THE OTHER ASSOCIATED LOW IMPEDANCE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379694 RESTORE EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37022

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR