BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2070172 · Received April 25, 2011

    Report

    Report Number
    3004209178-2011-03073
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    January 1, 2009
    Report Date
    April 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37713 (B)(4) SHOWED NO SIGNIFICANT ANOMALIES. SPECIFICALLY, THE BATTERY CAPACITY HAD BEEN REDUCED DUE TO OVERDISCHARGE. INITIALLY AS RECEIVED, THERE WAS NO OUTPUT (TELEMETRY) FROM THE DEVICE. TELEMETRY WAS DETERMINED TO BE OKAY AFTER A PHYSICIAN MODE RECHARGE WAS PERFORMED (RECOVERED NORMALLY). AFTER INTERROGATION, THE TOTAL RECHARGE COUNT WAS 16 AND THE LAST RECHARGE SESSION WAS NOTED AS THE DEFAULT IMPLANT DATE OF (B)(6), 2000. THE DEVICE WAS RECHARGED FOR 4 HOURS AND 34 MINUTES AND WAS CHARGED TO A LEVEL FROM 2.145 TO 3.775 VOLTS. THE DEVICE WAS THEN RE-INTERROGATED WHICH SHOWED NO PATIENT USAGE AND THAT THE BATTERY HAD DISCHARGE TO THE LOCK MODE ON (B)(6) 2000. THE COUPLING RECORD OF THE LAST 5 PATIENT RECHARGE SESSIONS SHOWED 1@75%, 2@50%, 1@25%, AND [email protected]%. GOOD STABLE OUTPUT WAS OBSERVED ON THE OUTPUT SETTINGS AS RECEIVED AND PASSED THE AUTOMATED TEST CONSOLE TEST.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE . 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD HAD COUPLING AND COMMUNICATION ISSUES SINCE IMPLANT AND DIFFICULTY MAINTAINING A CHARGE. THE NEUROSTIMULATOR HAD BEEN OVERDISCHARGED THREE TIMES AND NORMAL CHARGING COULD NOT BE RESTORED. SETTINGS WERE NOT ABLE TO BE OBTAINED FROM THE DEVICE. THE NEUROSTIMULATOR WAS REPLACED ON (B)(6) 2011 AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT WAS HAVING COUPLING AND OR COMMUNICATION ISSUES. IT WAS NOTED THAT THE PT HAD NOT CHANGED HER INS SINCE IMPLANT. THE STIMULATION HAD BEEN TURNED OFF. THE INS BATTERY WAS FLASHING AT THE 50% QUARTILE WITH NO COUPLING BARS. IN F/U REPORTING FROM THE HCP, IT WAS NOTED THAT THE CAUSE OF THE EVENT WAS THE INS WITH INADEQUATE COVERAGE. IMPEDANCE CHECK WITHIN NORMAL LIMITS. LUMBAR X-RAY WAS NOTED. THE PT HAD THE SPINAL CORD STIMULATOR REPLACED AND FELT THAT IT WAS NOW COVERING 100% OF HER PAIN. THE PT OUTCOME WAS NON-SERIOUS INJURY/ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention LEAD: MODEL 3998, LOT# V135519| EXTENSION: MODEL 37083, LOT# NKC017750N| EXTENSION: MODEL 37083, LOT# NKC016709N| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE127170N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA126965N| IMPLANTED:| EXPLANTED:| IMPLANTED: