Model Number 302-20 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/10/2019 |
Event Type
malfunction
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Event Description
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An implant form was received reporting explant and replacement of a patient's generator and lead.The form marked that the lead replacement was due to high impedance "bottom coil not attached".The reason for the generator replacement was not indicated on the form.Further follow up confirmed that the generator replacement was prophylactic.The explanted product has not been received to date.No other relevant information has been received to date.
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Manufacturer Narrative
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Report source, corrected data: initial report inadvertently did not list that a "foreign" medical facility was involved as a report source.
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Event Description
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After further follow up with the explanting facility, it was discovered that the explanted generator and lead had been misplaced and will not be returned.No other relevant information has been received to date.
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Event Description
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It was reported that the explanted generator was going to be returned and that it was unknown if the lead was also going to be returned.The explanted products have not been received by the manufacturer to date.
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Search Alerts/Recalls
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