BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3841326 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09851
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# LA4905, IMPLANTED: 2002 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IN SERIAL # (B)(4), FOUND NO SIGNIFICANT ANOMALY. WHEN RECEIVED FOR ANALYSIS THE INS BATTERY WAS DISCHARGED AND THE DEVICE WAS RECHARGED. ON (B)(6) 2014 AFTER RECHARGING THE BATTERY ABOVE THE ¿SLEEP¿ MODE, AN INITIAL REVIEW AND TRACE REPORT WERE OBTAINED FROM THE INS. IT SHOWED A 0X8 ¿VOLTAGE TOO LOW¿ POR HAD OCCURRED, HOWEVER, THE OVERDISCHARGE COUNT WAS STILL 0. AFTER RECHARGING TO FULL, THE INS PASSED THE NGT AND ACCELEROMETER TESTS. A RECHARGE INTERVAL TEST WAS PERFORMED WITH THE PARAMETERS SET AT 10.5 V AMP, 400US PW, 60HZ AND A 750 OHM LOAD. THE BATTERY DEPLETED FROM FULL TO ¿SLEEP¿ MODE IN 3.7 DAYS. THE EXPECTED DISCHARGE TIME OF A KNOWN GOOD DEVICE FROM A FULL BATTERY TO THE "SLEEP" MODE IS 3.5 DAYS. AFTER REACHING THE ¿SLEEP¿ MODE, IT WAS ALLOWED TO SIT OVER A WEEKEND. THE BATTERY VOLTAGE AT THE END OF THE WEEKEND WAS 3.615 VOLTS (¿SLEEP¿ MODE OCCURS AT 3.575 VOLTS, SO THE BATTERY WAS RECOVERING AND NOT DEPLETING RAPIDLY). DESTRUCTIVE ANALYSIS AT MTC PAL DID NOT REVEAL ANY ANOMALIES WITH THE HYBRID CIRCUIT. WHEN POWERED BY EITHER THE INTERNAL BATTERY OR AN EXTERNAL SUPPLY, PAL ANALYSIS VERIFIED THE DEVICE TO BE FULLY FUNCTIONAL WITH NOMINAL CURRENT DRAIN PROFILES IN ALL MODES OF OPERATION. THE DEVICE PASSED ALL FUNCTIONAL TESTING. NO COPPER TRACE ANOMALIES OR FOREIGN MATERIAL, REFERRED TO AS MUD CRACKING RESIDUE (MCR), WERE OBSERVED DURING OPTICAL INSPECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS EXPLANTED. IT WAS NOTED THAT THE PATIENT EXPERIENCED COUPLING ISSUES AND WAS ONLY ABLE TO GET 2 BARS AND THEN NONE. IT WAS NOTED THAT THE PATIENT WENT THRU 1/3 OF THE SLEEP MODE VOLTAGE RANGE IN 20 HOURS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECOVERED FROM THE SURGERY WITHOUT SEQUELA. IT WAS NOTED THAT THE PATIENT WAS ABLE TO CHARGE NORMALLY AND WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD TELEMETRY ISSUES. IT WAS NOTED, THE PATIENT LOST STIMULATION SENSATION THREE DAYS PRIOR TO CALL. IT WAS FURTHER NOTED THEIR PAIN HAD WORSENED SINCE THEN. IT WAS REPORTED THE PATIENT WENT TO RECHARGE THREE DAYS PRIOR TO CALL AND SAW THE REPOSITION ANTENNA SCREEN AFTER GETTING ONLY TWO COUPLING BARS. IT WAS NOTED, THE STIMULATOR WOULD NOT COMMUNICATE WITH THE PHYSICIAN PROGRAMMER, PATIENT PROGRAMMER, OR RECHARGER. IT WAS REPORTED, THE PATIENT HAD NOT RECHARGED SINCE IMPLANT TWO WEEKS PRIOR TO CALL. IT WAS NOTED, IT WAS UNKNOWN IF THE STIMULATOR WAS CHARGED PRIOR TO IMPLANT. IT WAS REPORTED ANTENNA LOCATE SHOWED A RANGE OF FORTY-SIX TO FIFTY. IT WAS NOTED, THE PATIENT PROGRAMMER SHOWED THE POOR COMMUNICATION SCREEN. IT WAS REPORTED, THE PATIENT HAD ATTEMPTED RECHARGING MULTIPLE TIMES, BUT COULD NOT GET COUPLING. IT WAS NOTED, TWO SHORT PHYSICIAN MODE RECHARGES DID NOT RESOLVE THE ISSUE. IT WAS REPORTED A FULL PHYSICIAN MODE RECHARGE (PMR) DID NOT RESOLVE THE ISSUE. IT WAS REPORTED TELEMETRY WAS NOT POSSIBLE AFTER THE FIRST PMR. IT WAS NOTED, THE STIMULATOR WAS DEEPER THAN NORMAL COMPARED TO OTHER PATIENTS. IT WAS REPORTED A FLIPPED STIMULATOR WAS UNLIKELY. IT WAS REPORTED, THE PATIENT HAD TO LEAVE DURING THE SECOND PMR. IT WAS NOTED NORMAL RECHARGING WAS AVAILABLE AFTER THE THIRD PMR. IT WAS REPORTED, THE BEST COUPLING ACHIEVED WAS TWO BARS, BUT NORMALLY ZERO. IT WAS NOTED, THE RAPID BATTERY DEPLETION HAD OCCURRED. IT WAS REPORTED, THEY ¿WILL HAVE TO DO A REVISION¿ FOR THE COUPLING ISSUE. IT WAS NOTED, THE PATIENT HAD SEEN THE THERMOMETER ICON ON THE RECHARGER. IT WAS REPORTED, THE PATIENT SAW THE ¿CALL YOUR DOCTOR¿ ICON. IT WAS REPORTED, THE PATIENT WAS BEING SCHEDULED FOR BATTERY REPLACEMENT AND POCKET REVISION. IT WAS REPORTED, THE PATIENT STILL HAD COUPLING ISSUES. IT WAS NOTED, THE PATIENT WAS SCHEDULED FOR REPLACEMENT ON 2014 (B)(6). IT WAS REPORTED, THE STIMULATOR COULD NOT BE INTERROGATED AT THE REPLACEMENT SURGERY DUE TO IT BEING DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318753 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention