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Model Number 6371 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Erosion (2075)
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Event Date 08/20/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.Additional components potentially involved in the event include: common device name: dbs extension, model: 6371, udi: (b)(4), serial: (b)(4), batch: 7726124 during processing of this incident, attempts were made to obtain complete event and patient information.Further information was requested but not received.
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Event Description
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It was reported that the patient¿s extension eroded through the skin.As such, surgical intervention took place on (b)(6) 2022 wherein the extensions were explanted to address the issue.The ipg was also electively explanted.Investigation was unable to determine which of the extensions attributed to the event.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Event Description
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Additional information received indicates that device 6371 sn 18824107 had eroded.
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Search Alerts/Recalls
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