BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4141128 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18309
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 9, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTH CARE PROFESSIONAL OFFICE HAD A CLINICIAN PROGRAMMER THAT HAD AN OLD SOFTWARE AAR CARD. WHEN THEY CHECKED THE PATIENT¿S DEVICE WITH THAT CLINICIAN PROGRAMMER, IT JUST COMPLETELY WIPED ALL THE PROGRAMS OFF THE PATIENT¿S BATTERY AS IF THE DEVICE HAD NEVER BEEN PROGRAMMED. THE MANUFACTURING REPRESENTATIVE WAS ABLE TO LOOK INTO THE CLINIC¿S RECORDS AND GET THE SETTINGS FOR THE PATIENT¿S OLD PROGRAMS. THE DEVICE WAS PROGRAMMED ACCORDINGLY AND A NEW SOFTWARE CARD WAS ORDERED FOR THE CLINIC AS WELL. A WEEK AFTER THAT APPOINTMENT, THE PATIENT WAS SEEN BY A MANUFACTURING REPRESENTATIVE WHO DID ADDITIONAL PROGRAMMING. SINCE THEN, THE PATIENT HAD BEEN RECEIVING EFFECTIVE THERAPY AND NO FURTHER ISSUES HAD BEEN REPORTED. IT WAS NOTED THAT THE CLINIC¿S CLINICIAN PROGRAMMER WAS WORKING FINE AS WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN APPOINTMENT WITH A HEALTH CARE PROFESSIONAL ONE WEEK PRIOR TO THE REPORT. THE HEALTH CARE PROFESSIONAL USED THE CLINICIAN PROGRAMMER ON THE PATIENT AND THOUGHT THE PATIENT HAD A PAIN PUMP. AFTER THE HEALTH CARE PROFESSIONAL WAS DONE THAT DAY, THE MANUFACTURING REPRESENTATIVE USED A CLINICIAN PROGRAMMER ON THE PATIENT AND NOTICED THAT ALL THE PROGRAMS HAD BEEN WIPED/CLEANED OUT. THE MANUFACTURING REPRESENTATIVE THEN INSTALLED ONE PROGRAM FOR THE PATIENT AND NOTED THAT IT SHOULD WORK, EVEN THOUGH THE PATIENT REQUESTED MORE THAN ONE. IT WAS NOTED THAT THE PATIENT WAS ONLY GIVEN THE AMPLITUDE OPTION. IT WAS NOTED THAT THE PATIENT¿S BATTERY WAS INTERROGATED WITH A CLINICIAN PROGRAMMER WITH AN OLD CARD BELONGING TO THE CLINIC PRIOR TO MEETING WITH THE PATIENT. THE PATIENT¿S BATTERY WAS REPROGRAMMED AND SHE WAS GETTING EXCELLENT COVERAGE AT THE TIME OF PROGRAMMING. THE REPORTER STATED THAT THE DEVICE WORKED BUT THE PROGRAM DID NOT PROVIDE THE PAIN RELIEF THAT THE PREVIOUS PROGRAMMING DID. IT WAS NOTED THAT THE PATIENT HAD A 10 SECOND DELAY PROGRAMMED BEFORE AND THAT WAS GONE TOO. IT WAS NOTED THAT THEY SUGGESTED THE PATIENT TRY THE NEW PROGRAM FOR A MONTH. THE PATIENT HAD BEEN TRYING THE PROGRAM SINCE ONE WEEK PRIOR TO THE REPORT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619129 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR