It was reported that a physician could not interrogate a vns patient's device on (b)(6) 2016.
It was reported that the day before, on (b)(6) 2016, the patient underwent surgery due to infection where the wound was cleaned without explanting the device (event reported in the medwatch report 1644487-2016-02050).
Before the surgery, the device was switched off without any issues.
The physician did not perform a diagnostics test, but there was no issue with the patient's generator.
After the surgery, when the physician tried to switch the device back on (on (b)(6) 2016), communication issues occurred.
The physician tried many times before she could finally interrogate the generator.
It then stated that the generator was at end of service.
The device was implanted in (b)(6) 2016 (2 months ago).
Diagnostics test showed: low output current, impedance ok, 2806 ohm, eos yes.
It was reported that another physician came to help using her programming system, but she could never communicate with the device.
Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
Further information from the physician indicated that, 10 days after the surgery they still could not interrogate the patient's generator.
As the infection was still there, it was decided to explant the device.
It was reported that the patient underwent explant surgery on (b)(6) 2016.
The return of the explanted device is expected but it has not been received to date.
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Further information from the surgeon was received indicating that during the surgery, an equipment could have touched the device, which could have caused the premature end of service.
The explanted generator was returned to the manufacturer on 10/31/2016.
Analysis is underway but it has not been completed to date.
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