Model Number 37602 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Complaint, Ill-Defined (2331)
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Event Date 04/18/2014 |
Event Type
Injury
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Event Description
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It was reported the left stimulator was visible and the wound was open.After the surgery a crust formed on the wound and when it fell off there was an open wound in which the stimulator was visible.The patient did not contact their physician at the time.The patient was hospitalized and the stimulator was explanted and not replaced.The event was related to the procedure and the outcome was ongoing.If additional information is received on outcome, a follow-up report will be sent.Refer to manufacturer report # 3004209178-2015-04537 it was unknown which stimulator was explanted and replaced.
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Manufacturer Narrative
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Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 338902836, lot# b9993681k, implanted: (b)(6) 2000, product type: lead.Product id: 338902836, lot# b9992982k, implanted: (b)(6) 2000, product type: lead.(b)(4).
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Event Description
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Additional information reported the stimulator and lead have been explanted without replacement at this time.A future system implant was planned.The event is resolved without sequelae.
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Manufacturer Narrative
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Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.
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Manufacturer Narrative
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Final analysis of the stimulator revealed no anomaly found.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Additional information received reported that the study center changed the clinical diagnosis from open wound, left stimulator visible to implant site erosion.The device diagnosis had been removed.Device diagnosis was entered as stimulator perforation.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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