BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3836555 · Received May 28, 2014

    Report

    Report Number
    3004209178-2014-09749
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    May 8, 2014
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1993, PRODUCT TYPE EXTENSION; PRODUCT ID 3587A, LOT# L30171, IMPLANTED: (B)(6) 1993, PRODUCT TYPE LEAD; PRODUCT ID 74001, LOT# N212477, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE STIMULATOR REVEALED NO SIGNIFICANT ANOMALIES. THE DEVICE WAS FUNCTIONALLY OK. FINAL ANALYSIS OF THE EXTENSION REVEALED NO SIGNIFICANT ANOMALIES. FINAL ANALYSIS OF THE LEAD REVEALED THAT CONDUCTORS WERE BROKEN WITHIN 10 CM OF THE CONNECTOR AREA. FINAL ANALYSIS OF THE ADAPTOR REVEALED NO ANOMALIES. FINAL ANALYSIS OF THE ANCHOR REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED FOR LEAD REPLACEMENT ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT GOT SURGES IN THE LOWER SPINE FROM THE DEVICE WHEN IT WAS ON. THIS STARTED A COUPLE OF DAYS AGO. THE PATIENT STATED THE IMPLANT WAS ¿ACTING UP.¿ WHEN SHE MOVED, SHE WOULD GET SURGES. SHE WOULD ALSO FEEL THE SURGES IF SHE PUT SOMETHING ON HER LAP OR IF HER CAR WENT OVER A BUMP. IT WAS CONSTANT AND WOULD LAST A FEW MINUTES. THERE WERE NO FALLS OR TRAUMA. IT WENT AWAY IN CERTAIN POSITIONS. THE PATIENT TURNED THE DEVICE OFF THE NIGHT PRIOR TO THE REPORT AND HADN¿T FELT THE SURGING SINCE. THE PATIENTS PHYSICIAN HAD MOVED AND THE PATIENT WAS TRYING TO LOCATE A NEW PHYSICIAN AS WELL AS HER MEDICAL RECORDS. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE WOULD SHIP THE EXPLANTED DEVICE ON MONDAY (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SAW A MANUFACTURER REPRESENTATIVE ON (B)(6) 2014 AND HAD THEIR DEVICE REPROGRAMMED AND GOT 3 PROGRAMS. IT WAS NOTED THAT PROGRAM C WAS THE BEST BUT THE SAME THING HAPPENED. THE PATIENT WOULD REPORTEDLY HAVE GOOD STIMULATION FOR A WHILE AND COULD FEEL THE STIMULATION WAS GOOD, AND THEN THE STIMULATION WOULD GO DOWN AND THEY COULD HARDLY FEEL IT. IT WAS NOTED THAT THE PATIENT'S LEADS HAD BEEN IN FOR "20 SOME YEARS" AND THEY WERE PROBABLY WORE OUT. IT WAS FURTHER REPORTED THAT THEY WANTED TO INCREASE THE LENGTH OF THE RODS IN THEIR BACK BECAUSE THE PATIENT WAS HAVING PAIN. IT WAS NOTED THAT BECAUSE OF THE PAIN THE PATIENT COULD NOT STAND UP STRAIGHT AND THAT MAY HAVE CAUSED A PROBLEM WITH THE WIRES ALSO. THE PATIENT WAS REPORTEDLY WAITING FOR A CALL FROM THEIR HEALTH CARE PROVIDER (HCP) TO SCHEDULE A PROCEDURE FOR A NEW DEVICE AND WIRES. IT WAS LATER REPORTED THAT THERE WAS A FADING SENSATION AND THEY NEEDED TO INCREASE AMPLITUDE. A MANUFACTURER REPRESENTATIVE REPORTEDLY MET WITH THE PATIENT ON THE DAY PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT WAS RE-PROGRAMMED AND WAS GETTING GOOD STIMULATION AND GOOD LOCATION IN BACK AND LEGS. THE PATIENT WAS SENT HOME BUT CALLED BACK ON THE DAY OF THE REPORT TO AND STATED THAT AN INCREASE IN STIMULATION WAS REQUIRED ABOUT EVERY HOUR. NO POSITIONAL CHANGES WERE NOTED DURING INCREASE. THE MANUFACTURER REPRESENTATIVE DID NOT KNOW WHEN THE ISSUE STARTED AND THE PATIENT DID NOT HAVE A MANAGING HEALTH CARE PROVIDER (HCP). A POSSIBLE LEAD ISSUE AND A SURGICAL REVISION OF THE LEAD OR EXTENSION WERE DISCUSSED. IT WAS ALSO UNKNOWN WHAT THE VOLTAGE LEVEL WAS AT THE TIME OF THE REPORT. IT WAS LATER REPORTED THAT NO CAUSE OF THE ISSUE WAS DETERMINED AND THE ELECTRODE IMPEDANCES WERE NORMAL UPON INTERROGATION. THE SYSTEM WAS REPROGRAMMED BUT POST 24 HOURS THE PATIENT REPORTED INCREASING THE DEVICE TO PROVIDE STIMULATION ON AN HOURLY BASIS. THE PATIENT WAS INSTRUCTED TO KEEP A LOG OF INCREASING AND WHAT POSITION THE PATIENT WAS IN AT THE TIME OF THE INCREASES. IT WAS FURTHER REPORTED THAT THE DEVICE FADED HOURLY AND HAD NO BEARING ON POSITION. IT WAS THEN NOTED THAT THE LEAD MAY HAVE BEEN THE CAUSE OF THE INCREASING AMPLITUDES AND LACK OF COVERAGE AT PRIOR SETTINGS. THE PATIENT WAS REPORTEDLY AWAITING AN APPOINTMENT TO SCHEDULE A LEAD REVISION. THE PATIENT WAS REPORTEDLY REVIVING THERAPY BUT HAD TO INCREASE AMPLITUDE TO MAINTAIN COVERAGE. IT WAS LATER REPORTED THAT THERE WAS A FADING SENSATION. THE PATIENT WAS REPORTEDLY REPROGRAMMED BUT THE FADING WAS STILL OCCURRING. ELECTRODE IMPEDANCES WERE WITHIN NORMAL RANGE PER THE MEASUREMENTS PROVIDED ON THE DAY OF THE REPORT. IT WAS NOTED THAT THEY WERE LOOKING AT THE LEAD AS A POSSIBLE CAUSE DUE TO THE AGE OF THE LEAD AND THAT THE PATIENT WAS GETTING A CHANGE IN THERAPY RESPONSE AND WAS NOT GETTING THE COVERAGE THEY NEEDED. IT WAS FURTHER NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ONLY TWO YEARS OLD, THE PATIENT WAS FEELING STIMULATION, THE IMPEDANCES WERE NORMAL, AND THEY WERE TO LOOKING AT THE INS AS THE ISSUE AT THAT TIME. IMPEDANCES IN OHMS WERE NOTED AS 0/1 1091, 0/2 1864, 0/3 1210, 1/2 1474, 1/3 1084, 2/3 1474.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCES HAD CHANGED. ON THE DAY OF THE REPORT, THEY WERE 01=918, 02=1777, 03=1046, 12=1461, 13=995, 23=1446. (TESTED AT THE DEFAULT .7V). IT WAS NOTED THAT LAST TIME THEY WERE 01=1091, 02=1864, 03=1210.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PROCEEDED WITH HER LEAD REPLACEMENT ON (B)(6) 2014. THE SURGEON DID NOTICE INSULATION DETE RIORATION AT THE DISTAL END OF THE LEAD WIRES. THE PATIENT RECEIVED THERAPY AFTER THE REVISION.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD HER DEVICE OFF AS IT "WENT HAYWIRE." WHEN SHE MOVED THE STIMULATION WENT "REAL HIGH" AND WAS PAINFUL. SHE WOULD TURN IT DOWN AND IT WOULD GO BACK TO NORMAL UNTIL SHE MOVED AGAIN, AND THEN IT WOULD HAPPEN AGAIN. THE PATIENT EVENTUALLY TURNED STIMULATION OFF. THE ISSUE CAME ON SUDDENLY. THE PATIENT SAW A NEW MANAGING PHYSICIAN. XRAYS WERE DONE BUT THE PHYSICIAN WAS NOT SURE WHAT THE CAUSE WAS. IT WAS STATED THAT THE PHYSICIAN WOULD SCHEDULE A COMPANY REPRESENTATIVE FOR REPROGRAMMING AND A SYSTEM CHECK TO SEE IF THE "WIRING NEEDS TO BE PULLED OUT." THE PATIENT STATED THAT SHE HAD "RODS" IMPLANTED IN HER SPINE, AND THEY NEEDED TO BE EXTENDED, BUT THE PHYSICIAN WANTED TO CHECK THE DEVICE BEFORE DOING THIS FIRST. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312993 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention