Model Number 302-20 |
Device Problems
Low impedance (2285); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/23/2016 |
Event Type
malfunction
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Event Description
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Clinic notes were received on (b)(6) 2016 and dated (b)(6) 2016.It was stated there was a warning message that there was low impedance < 600 ohms.The patient denies any unusual stimulation or shock-like sensations.The device was interrogated again on (b)(6) 2016 and it was stated impedances were fine.No surgical intervention has occurred to date.No additional information has been received to date.
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Event Description
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The patient was seen again in the physician's office, and the diagnostics showed that impedance was within normal limits.The patient refused surgery at that time because the impedance was within normal limits, even though low impedance was seen at a previous office visit.No surgical intervention has occurred to date.
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Event Description
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An implant card was later received reporting that the patient had a full revision due to the low impedance.Impedance values were within normal limits with the new devices.The explanted suspect device (lead) is not available for return to the manufacturer.No other relevant information has been received to date.
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Search Alerts/Recalls
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