BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 7436251 · Received April 17, 2018

    Report

    Report Number
    3004209178-2018-08179
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    January 1, 2018
    Report Date
    April 18, 2018
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4). INVESTIGATION SUMMARY - IT WAS REPORTED THAT THE POWER ON RESET WARNING APPEARED ON INS RECHARGER WHEN PATIENT WAS LAYING IN BED AND ALL SUDDEN THE STIMULATOR STOPPED WORKING. AS THE EVENT WAS REPORTABLE TO A REGULATORY AUTHORITY AND INDICATED A POSSIBLE FAILURE OF A DEVICE, LABELING, OR PACKAGING TO MEET ANY OF ITS SPECIFICATIONS, AN INVESTIGATION WAS REQUIRED. THE EVENT WAS INVESTIGATED TO DETERMINE CAUSE. AS THE DEVICE WAS STILL IN USE AT THE TIME THIS INVESTIGATION WAS COMPLETED, NO ANALYSIS COULD BE PERFORMED. THERE WAS NO INDICATION THAT THE EVENT WAS RELATED TO A POSSIBLE MANUFACTURING ISSUE, SO A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED. THE INVESTIGATION DETERMINED THAT THERE WAS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE EVENT. THE ROOT CAUSE WAS NOT REPORTED TO THE MANUFACTURER, AND WAS UNABLE TO BE OBTAINED THROUGH FOLLOW-UP REQUESTS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT A LATER DATE, THE INVESTIGATION WILL BE RE-OPENED AND UPDATED ACCORDINGLY. (B)(4): INVESTIGATION SUMMARY - IT WAS REPORTED THAT THE PATIENT HAD THERAPY STOPPED DUE TO POWER ON RESET (POR), AND ALL SUDDEN HER STIMULATOR STOPPED WORKING WHEN SHE WAS LAYING IN BED. AS THE EVENT WAS REPORTABLE TO A REGULATORY AUTHORITY AND INDICATED A POSSIBLE FAILURE OF A DEVICE, LABELING, OR PACKAGING TO MEET ANY OF ITS SPECIFICATIONS, AN INVESTIGATION WAS REQUIRED. ADDITIONAL INFORMATION WAS REQUIRED TO DETERMINE THE CAUSE OF THE EVENT. THE PATIENT WAS CONTACTED TO INVESTIGATE WHAT CIRCUMSTANCES THAT LED TO ALL SUDDEN HER STIMULATOR STOPPED WORKING, RECHARGER SHOWED POWER ON RESET, AND WHETHER THE REPLACEMENT OF THE PROGRAMMER RESOLVES THOSE ISSUES ABOVE. AS THE DEVICE WAS STILL IN USE AT THE TIME THIS INVESTIGATION WAS COMPLETED, NO ANALYSIS COULD BE PERFORMED. THERE WAS NO INDICATION THAT THE EVENT WAS RELATED TO A POSSIBLE MANUFACTURING ISSUE, SO A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED. THE SUSPECTED CAUSE OF THE EVENT IS THE POWER ON RESET WARNING ON INS RECHARGER AND THAT CAUSED THE THERAPY STOPPED. HOWEVER, THE POWER ON RESET WARNING ON INS RECHARGER AND THAT CAUSED THE THERAPY STOPPED WAS NOT REPORTED TO THE MANUFACTURER, AND WAS UNABLE TO BE OBTAINED THROUGH FOLLOW-UP REQUESTS. THUS, THE CAUSE OF THE EVENT COULD NOT BE CONFIRMED. THE INVESTIGATION DETERMINED THAT THERE WAS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT A LATER DATE, THE INVESTIGATION WILL BE RE-OPENED AND UPDATED ACCORDINGLY. PRODUCT ID (B)(4) SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID (B)(4) SERIAL# (B)(4): PRODUCT TYPE RECHARGER. 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT AT LATER DAY. IT WAS STATED A TECHNICIAN FROM REPAIR WAS ABLE TO HELP HER GET THE PROGRAMMER WORKING AFTER SHE REPLACED THE BATTERIES IN IT. PATIENT STATED THE REPAIR STILL SENT HER A REPLACEMENT PROGRAMMER BECAUSE THERE WAS A CORROSION IN THE BATTERY COMPARTMENT. PATIENT CALLED BACK BECAUSE OF INFORMATION POR ON THE SCREEN WHILE COMMUNICATION HER PROGRAMMER WITH INS. PATIENT ASKED PATIENT SERVICES (PSS) IF THE POR COULD BE CLEARED, IT WAS REVIEWED THE POR COULD BE CLEARED WITH PP. PP WOULD NOT BYPASS THE POR TO CLEAR IT AND WAS STUCK ON THE POR SCREEN AND PP WAS SHOWING POOR COMMUNICATION. PSS ASKED PATIENT TO CALL BACK FOR ASSISTANCE CLEARING THE INFORMATION POR WHEN PATIENT RECEIVED REPLACEMENT PP. NO FURTHER COMPLICATION AND NO SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR RADICULAR PAIN SYNDROME ( RADICULOPATHIES). IT WAS REPORTED THE PATIENT HAD THERAPY STOPPED DUE TO POWER ON RESET (POR). IT WAS STATED PATIENT WAS LAYING IN BED AND ALL SUDDEN HER STIMULATOR STOPPED WORKING AND WHEN SHE CHECKED HER RECHARGER, IT SHOWED A WARNING POR. IT WAS NOTED THE PATIENT VIEWED POR ON RECHARGER, PATIENT PROGRAMMER (PP) WAS UNAVAILABLE AS THERE WAS CORROSION IN THE BATTERY COMPARTMENT. DUE TO THE TYPE OF PP, TROUBLESHOOTING COULDN¿T BE DONE. PATIENT SERVICES (PSS) TRANSFERRED PATIENT TO REPAIR TO GET A REPLACEMENT PROGRAMMER. PSS REDIRECTED PATIENT TO HCP TO HAVE POR CLEARED. IT WAS NOTED THE PROGRAMMER HAD CORROSION IN THE BATTERY COMPARTMENT. NO FURTHER COMPLICATION AND NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279822 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR