BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2536482 · Received April 16, 2012

    Report

    Report Number
    3004209178-2012-02376
    Event Type
    Injury
    Date Received
    April 16, 2012
    Report Date
    March 21, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL 37083-60, SERIAL# (B)(4), IMPLANTED (B)(6) 2009, EXPLANTED UNK; EXTENSION MODEL 37083-60, SERIAL# (B)(4), IMPLANTED (B)(6) 2009, EXPLANTED UNK; LEAD MODEL 3888-45, LOT# V126618, IMPLANTED (B)(6) 2009, EXPLANTED UNK; LEAD MODEL 3888-45, LOT# V126618, IMPLANTED (B)(6) 2009, EXPLANTED UNK; PROGRAMMER MODEL 37743, SERIAL# (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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS FOR INS (B)(4) REVEALED THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. DEVICE ANALYSIS FOR LEAD (B)(4) REVEALED NO ANOMALY FOUND. DEVICE ANALYSIS FOR EXTENSION (B)() REVEAL NO SIGNIFICANT ANOMALY. THE BODY OUTER INSULATION WAS MELTED. DEVICE ANALYSIS FOR EXTENSION (B)(4) REVEAL NO SIGNIFICANT ANOMALY. THE BODY OUTER INSULATION WAS MELTED. DEVICE ANALYSIS FOR LEAD (B)(4) REVEALED THE DISTAL END CONDUCTOR WAS BROKEN. THE #3 WIRE WAS BROKEN AT THE ELECTRODE WELD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVERDISCHARGED. COUPLING DIFFICULTIES EXISTED PRIOR TO OVERDISCHARGE AND WERE CITED AS THE PRIMARY REASON FOR THE OVERDISCHARGE EVENT. THE PATIENT LAST RECHARGED AND FELT STIMULATION 6 TO 12 MONTHS PRIOR TO REPORT. EIGHT PHYSICIAN-MODE-RECHARGE SESSIONS WERE ATTEMPTED WITHOUT SUCCESS. THE INS WAS STILL IN AN OVERDISCHARGED STATE AND THE PATIENT WAS NOT RECEIVING THERAPY. THE PATIENT WAS SCHEDULED TO SEE THE IMPLANTING NEUROSURGEON. A REVISION HAD NOT YET BEEN SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT'S INSURANCE EXPIRED. THE PATIENT WAS NOT DOING GOOD AND NOT RECEIVING THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WOULD LIKE HER DEVICE REMOVED OR REPLACED. IT WAS STATED THAT THE PATIENT HAS NEW INSURANCE THAT DENIED HER RECEIVING A NEW DEVICE. IT WAS STATED THAT EVEN THOUGH THE DEVICE IS NOT ON, SHE WAS STILL RECEIVING A SHOCKING OR JOLTING SENSATION ON THE BACK OF HER HEAD. IT WAS REPORTED THAT THESE SENSATIONS WERE RANDOM AND COULD HAPPEN FOR 2-3 DAYS AND THEN NOTHING WOULD HAPPEN FOR A "COUPLE" OF MONTHS. IT WAS STATED THAT THE PATIENT PLANNED TO CONTINUE TO WORK WITH HER PHYSICIAN. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT'S SYSTEM WAS EXPLANTED BECAUSE A FEW YEARS AFTER IMPLANT, THE BATTERY WOULD NOT KEEP A CHARGE VERY LONG AND CHARGING TOOK A VERY LONG TIME AND WAS BURDENSOME. IT WAS ALSO REPORTED, THE PATIENT SOMETIMES RECEIVED UNCOMFORTABLE JOLTS DURING THERAPY. IT WAS STATED, THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION AND A LOSS OF STIMULATION/THERAPEUTIC EFFECT. IT WAS REPORTED, THE INS HAD UNDERGONE PREMATURE BATTERY DEPLETION. IT WAS NOTED, THE PATIENT WAS ALIVE WITH NO INJURY AND WAS DOING OK AT THE TIME OF FOLLOW-UP. IT WAS ADDITIONALLY NOTED, THE REPORTING MANUFACTURER REPRESENTATIVE HAD POSSESSION OF THE EXPLANTED COMPONENTS AND WAS TO RETURN THEM TO THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    THE PATIENT OUTCOME WAS ADDITIONALLY REPORTED AS RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE SPECULATED THAT THE BATTERY WAS IMPLANTED TOO DEEP. HE COULD NOT RECALL FOR SURE. THE PATIENT WAS NEVER ABLE TO GET MORE THAN 4 BARS. THE PATIENT WAS STILL TRYING TO APPEAL THE INSURANCE COMPANIES DENIAL.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE DEVICE WAS CAUSING A CUTANEOUS ALLERGY REACTION.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED INDICATED THAT PATIENT'S REQUEST FOR INS REVISION/REPLACEMENT WAS DENIED BY HER INSURANCE PROVIDER. SHE WAS APPEALING THE CASE. 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 00039 YR Required Intervention