BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2800357 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09412
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    September 24, 2012
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION; PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION; PRODUCT ID: 74002, LOT#: N305394, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER; PRODUCT ID: 37752, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID: 37744, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3487A, LOT#: L68482, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD; PRODUCT ID: 3487A, LOT#: L69341, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE LAST FOUR WEEKS THE PATIENT'S DEVICE WAS TAKING A LONG TIME TO CHARGE AND SHE WAS CHARGING MORE FREQUENTLY THAN BEFORE, ALTHOUGH THE DEVICE WAS ALWAYS "ACTING CRAZY". IT USED TO TAKE ONE DAY TO CHARGE AND WOULD LAST FOR A WEEK, NOW IT TAKES 3-4 DAYS TO FULLY CHARGE. NO FALLS/TRAUMAS AND/OR WEIGHT GAIN/LOSS WERE REPORTED AND SHE WAS USING THE SAME SETTINGS. THE PATIENT FELT A WARM SENSATION IN OR AROUND THE DEVICE POCKET DURING RECHARGING. IT WAS ALSO REPORTED THAT THERE WERE COUPLING/COMMUNICATION ISSUES. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE OR THERAPY, BUT SHE WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE. AN APPOINTMENT DATE OF (B)(6) 2012 WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT AT AN OFFICE VISIT REGARDING DIFFICULTIES RECHARGING THE DEVICE. THE PATIENT WAS ABLE TO DEMONSTRATE PROPER USE OF THE RECHARGER WITH HER DEVICE AND HAD NO ISSUES IN THE OFFICE. THE REPORTER STATED THAT A DEMONSTRATION RECHARGER WAS USED AND WAS ABLE TO RECHARGE THE DEVICE. IT WAS THEN STATED THAT THE REPORTER LET THE PATIENT BORROW THE DEMONSTRATION RECHARGER TO TEST OUT AND INFORMED THE PATIENT THAT HE WOULD CONTACT HER IN A FEW DAYS TO SEE IF THE LOANER WAS BETTER THAN THE PATIENT'S RECHARGER. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE HAD NOT BEEN ABLE TO GET IN CONTACT WITH THE PATIENT. THE MANUFACTURER REPRESENTATIVE WOULD FOLLOW UP WITH THE HEALTHCARE PROFESSIONAL (HCP) AT THE PATIENT'S NEXT APPOINTMENT. THE PATIENT OUTCOME WAS UNKNOWN. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE RECHARGER WAS REPLACED BECAUSE THE PATIENT COULD NOT FULLY CHARGE. THE PATIENT OUTCOME WAS LISTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00063 YR