BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2781372 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09084
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 25, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: RECHARGER. PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN "INTENSE JOLTING" SENSATION THAT HAD OCCURRED ON AND OFF SINCE THE DEVICE WAS IMPLANTED, BUT WOULD GO AWAY WHEN HE WOULD CHANGE POSITIONS. IN THE LAST TWO WEEKS, THE SHOCKING HAS STAYED MORE CONSISTENT. THE PATIENT'S SYMPTOMS WERE LOCATED IN HIS ABDOMEN, NOT AROUND IMPLANTED COMPONENTS. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS ISSUE. IT WAS ALSO REPORTED THAT THE PATIENT WAS CHARGING MORE THAN EXPECTED. THIS PAST WEEKEND THE DEVICE JUST SHUT OFF EVEN THOUGH THE PATIENT HAD CHARGED TWO DAYS BEFORE. HE TYPICALLY ONLY NEEDED TO CHARGE ONCE A WEEK AND NEVER GOT BELOW HALF. A DAY AND A HALF LATER, THE DEVICE SHUT OFF AGAIN AND WAS COMPLETELY DEAD AGAIN. THERE WAS NO CHANGE IN THE PARAMETERS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE DISPLAY SHOWED THE "CALL YOUR DOCTOR" ICON AND AN OOR (OUT OF RANGE) CONDITION. THE PATIENT FIRST SAW THIS MESSAGE LAST NIGHT AND GOT THE MESSAGE RIGHT AFTER RECHARGING. THE PATIENT WAS ABLE TO TURN STIMULATION UP ON THE NUMBER ONE LEAD, BUT ON THE NUMBER 2 LEAD HE COULD NOT INCREASE AND GOT THE OOR MESSAGE WHEN HE TRIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHENEVER THE PATIENT WOULD ADJUST STIMULATION, AN OUT OF REGULATION (OOR) ERROR CODE WOULD BE SEEN. THE REPORTER STATED THAT ADJUSTING THE SETTING AND LIMITS TO CUSTOM (FROM FULL RANGE) DID NOT RESOLVE THE ISSUE. IT WAS STATED THAT THERE WAS A LOW IMPEDANCE VALUE ON ELECTRODES 11 AND 12 (<(><<)> 150 OHMS). IT WAS NOTED THAT THE PATIENT WAS USING ELECTRODES 8, 10, 11, AND 12 "(9, 13, 14, AND 15 WERE QUESTIONABLE)." WITH ELECTRODE 8 AS A REFERENCE, THE REMAINING PROGRAMMED ELECTRODES "IMPENDENCE VALUES WERE 18,000 OHMS". THE REPORTER STATED THAT ELECTRODES 11 AND 12 WERE "SHORTED." IT WAS NOTED THAT ELECTRODE 12 (12+) WAS REMOVED FROM THE PROGRAM. SUBSEQUENT INFORMATION REPORTED THAT NO FURTHER DIAGNOSTICS WERE DONE. THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS STATED THAT THE DEVICE WAS PROGRAMMED AROUND THE SHORTED CONTACTS. THE PATIENT WAS GOING TO FOLLOW-UP WITH HIS HEALTH CARE PROVIDER (HCP). ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

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