Model Number 3660 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.
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Event Description
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Related mfr report: 3006705815-2020-31448.It was reported during the implanting of the scs stimulator, the physician had difficulty inserting the lead into the device to the end of the channel.The physician attempted many times in many ways in both the ipg channels without success.At the end the physician decided to lose the first contacts and to align the remaining contacts of the lead in the ipg header.There were no adverse consequences for the patient, and the appropriate stimulation therapy was achieved for the patient postoperatively.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information and images received, the cause of the reported event could be confirmed.
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Event Description
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Related mfr report: 3006705815-2020-31448.
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Search Alerts/Recalls
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