Model Number MN10450-50A |
Device Problem
High impedance (1291)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Date 04/01/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient was experiencing ineffective coverage of pain relief due to high impedances on all leads.As such surgical intervention took place where the leads were explanted and replaced in order to restore therapy.
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Manufacturer Narrative
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B3- date of event is estimated.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Manufacturer Narrative
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Correction: section d4: the seral number should have been sn# (b)(6), batch /lot# 7646565 and expiration date 09/15,2022 rather than batch # ab2270 and expiration date 03/27/2019.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Additional information received indicated all four leads were fractured which was confirmed by x-ray and visibly seen.
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Search Alerts/Recalls
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