BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2529432 · Received April 12, 2012

    Report

    Report Number
    3004209178-2012-02312
    Event Type
    Injury
    Date Received
    April 12, 2012
    Report Date
    March 19, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # CHANGED FROM P970004 TO P840001. (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (PRODUCT# 37712, SERIAL# (B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE BATTERY HAD A REDUCED CAPACITY DUE TO OVERDISCHARGE. ANALYSIS DATA SUGGESTED POOR COUPLING BETWEEN THE RECHARGE ANTENNA AND THE INS. TESTING OF THE RECHARGE FUNCTION OF THIS INS FOUND IT TO BE FUNCTIONING NORMALLY.

    Additional Manufacturer Narrative · 1

    LEAD MODEL 39565-65, SERIAL #(B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA, PROGRAMMER MODEL 37743, SERIAL #(B)(4), RECHARGER MODEL 37752, SERIAL #(B)(4), PROGRAMMER MODEL 37742, SERIAL #(B)(4), (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT PLANNED SURGICAL REVISION WAS ON HOLD UNTIL FURTHER NOTICE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD COUPLING/COMMUNICATION ISSUES WITH HER IMPLANTABLE NEUROSTIMULATOR (INS). WHEN THE ANTENNA LOCATOR FEATURE ON THE EXTERNAL RECHARGER WAS USED, SHE WAS ONLY ABLE TO GET A READING OF 26-30. IT WAS SUSPECTED THAT THE INS WAS EITHER FLIPPED OR WAS IMPLANTED TOO DEEP. THE PATIENT WAS SCHEDULED FOR AN X-RAY IN (B)(6) 2012. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED INDICATED THAT THE INS WAS NOT FLIPPED (PER X-RAY) BUT WAS IMPLANTED TOO DEEP. THE PATIENT WAS SCHEDULED FOR A REVISION OF THE INS POCKET (DATE UNKNOWN). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT LET HER DEVICE GO INTO DEEP DISCHARGE ABOUT A YEAR AGO. THE DEVICE WAS REPLACED WITH A NON-RECHARGEABLE DEVICE. THE PATIENT REPORTED IT WAS DIFFICULT TO RECHARGE. FURTHER INFORMATION RECEIVED REPORTED THAT THE REASON FOR REMOVAL WAS DEVICE RELATED, DIFFICULTY RECHARGING. THE PATIENT HAD DIFFICULTY RECHARGING AND EVENTUALLY COULD NOT CHARGE AT ALL. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED ORIGINALLY IT WAS THOUGHT THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD FLIPPED, BUT IT WAS LATER DETERMINED THAT THE INS WAS IN "TOO DEEP OF A POCKET."

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE PHYSICIAN REPORTED THAT THE INS WAS FLIPPED AND THAT SURGICAL INTERVENTION WAS PENDING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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 00037 YR Required Intervention