Additional method code: no further information was provided regarding this pt who resides and was implanted outside the usa.
This is the final report.
Clinical summary: 4yr old boy visited clinic on 18 august 99 since the implant system suddenly stopped working.
Parents stated that the boy fell from his bicycle a few days before, but he did not even hurt (no head injury) and the exprit was not damaged.
Clinic's investigation revealed that the telemetry wasn't working aymore and the patient wasn't responding to stimulation.
Integrity test confirmed device failure-no output and no telemetry.
Visual inspection: the implant was returned to cochlear ltd.
Without esd protective packaging.
Stiffening ring s1 was o;bserved to be crushed.
The intracochlear electrode lead was severed and the ball electrode not returned to cochlear ltd.
Cracks were observed in the silicone on the bottom side of the stimulator body.
A cut was observed in the silicone on the side of the stimulator body.
Several marks were observed on the extracochlear plate electrode.
A dent was observed in the titanium case on top side of the stimulator body.
X-rays of the unit revealed a crack in the hybrid integrated circuit.
Electrical tests: unit failed telemetry response and reflected impedance tuning tests.
Continuity betwee the electrode rings was checked, via the integrated circuit.
14 electrodes were found to be open circuit.
Conclusion: implant failed due to a cracked hybrid integrated circuit.
Electrode lead damage was observed.
It cannot be ruled out that the damage to the electrode lead occurred during explantation as the investigation, including clinical evidence did not yield any other probable cause.
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