BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5678628 · Received May 25, 2016

    Report

    Report Number
    3004209178-2016-10274
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    July 1, 2012
    Report Date
    July 5, 2016
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3888-45, LOT# V177972, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V162341, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-33, LOT# V160153, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-33, LOT# V160153, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER; PRODUCT ID 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES: THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3888-45, LOT# V162341, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V177972, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-33, LOT# V160153, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3487A-33, LOT# V160153, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-45, LOT# V177972, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V162341, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V160153, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V160153, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CONSUMER REPORTED ON (B)(6) 2012 THAT THERE WAS STIMULATION IN THE WRONG LOCATION IN 2012; THE PATIENT NO LONGER FELT STIMULATION ON THE RIGHT SIDE OF HER BACK, SHE FELT STIMULATION IN HER "RIDE" ALONG RIB CAGE. WHEN ASKED WHEN THIS STARTED, THE PATIENT STATED THAT IT HAD MIGRATED SLOWLY. NO PATIENT FALLS WERE REPORTED. THE PATIENT WAS REPROGRAMMED ONCE, BUT "COULD GET STIMULATION BACK IN CORRECT SPOT." THE PATIENT STATED IF SHE CANNOT GET THE RIGHT CARE FOR HER DEVICE IT WILL HAVE TO COME OUT. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED ON (B)(6) 2012 THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THE DEVICE/THERAPY; THE PATIENT DID NOT HAVE A MANAGING HEALTHCARE PROFESSIONAL AND A MANUFACTURER REPRESENTATIVE DID NOT CALL THE PATIENT BACK. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER VIA THE MANUFACTURER REPRESENTATIVE REPORTED ON (B)(6) 2016 THAT THERE WAS A CHANGE IN STIMULATION. THE CONSUMER REPORTED THAT THE LEAD SLIPPED, HOWEVER THE PATIENT DID NOT STATE HOW SHE KNEW THIS. IN ADDITION, THE PATIENT FELT STIMULATION IN THE STOMACH AND RIBS, NOT IN HER BACK. DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS NOT PERFORMED AT THIS TIME AS THE PATIENT WAS NO LONGER SEEING THEIR PREVIOUS MANAGING HEALTHCARE PROFESSIONAL. THE ISSUE WAS NOT RESOLVED AS OF (B)(6) 2016, AND THE PATIENT'S STATUS WAS ALIVE WITH NO INJURY. SURGICAL INTERVENTION WAS NOT PERFORMED, AND IT WAS UNKNOWN WHETHER SURGICAL INTERVENTION WAS PLANNED. THE PATIENT WAS NOT SURE IF SHE WOULD LIKE TO GET THE BATTERY REPLACED OR IF SHE WANTED THE WHOLE SYSTEM REMOVED; THE PATIENT DID NOT WANT SURGERY AT THIS TIME. THE PATIENT'S INDICATIONS FOR USE INCLUDED LUMBAR RADICULOPATHY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CIRCUMSTANCES THAT LED TO THE ISSUES OF THE LEADS HAVING SLIPPED, EXPERIENCING A CHANGE IN STIMULATION, AND STIMULATION FELT IN THE WRONG LOCATION WAS UNKNOWN. STEPS TAKEN OR PLANNED TO RESOLVE THE ISSUE WAS THAT CORRECTIVE SURGERY WAS TALKED ABOUT OR SURGERY TO REMOVE THE LEAD. THE ISSUE HAD NOT BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334540 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 52 YR