ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD
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Model Number 3186 |
Device Problem
Impedance Problem (2950)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
Injury
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Manufacturer Narrative
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B3: date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs lead, model: 3186, udi: (b)(4), serial:(b)(6), batch: a000113045.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.
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Event Description
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It was reported patient is experiencing an impedance issue on one of their leads and is unable to place their ipg into mri mode due to this issue.As such surgical intervention is pending to address the issue.
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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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It was reported patient underwent surgical intervention on (b)(6)2024, where both of the leads were replaced since scar tissue around the anchors led to replacing both leads.Therapy was restored.One and therapy was restored.
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Search Alerts/Recalls
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