Model Number 2100 |
Device Problem
Fracture (1260)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 10/30/2017 |
Event Type
Injury
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Event Description
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A double lead repair was done at (b)(6) on (b)(6) 2017 during a normal ipg replacement.Ipg (b)(4) was replaced with (b)(4).The right lead was severed, and the terminal pin was missing, so that lead was fixed first.Dr.(b)(6) successfully repaired the lead resulting in an impedance of 349.Neo lead repair kit (b)(4) was used to repair the right lead.The outer coil on the left lead was stretched out between the terminal pin and tubing around the lead serial number label, but it still showed good connectivity with an impedance of 377.To reinforce this section of the lead, dr.(b)(6) put a tube around this portion and filled it with silicone adhesive.The final impedance for the left lead was 376.The patient had not been experiencing any symptoms leading up to the ipg replacement and lead repairs.
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Manufacturer Narrative
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Evaluation of the returned device included the ipg (serial number (b)(4)) and part of the right lead (serial number (b)(4)).There were no anomalies found with the ipg, and it was functioning as intended when analyzed.The portion of the lead returned included a section with the serial number and a stretched out section of the coil.The lead was returned in two sections.The area of the lead that was fractured due to the design issue was not returned.
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Event Description
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A double lead repair was done at (b)(6) on (b)(6) 2017 during a normal ipg replacement.Ipg (b)(4) was replaced with (b)(4).The right lead was severed, and the terminal pin was missing so that lead was fixed first.Dr.(b)(6) successfully repaired the lead resulting in an impedance of 349.Neo lead repair kit (b)(4) was used to repair the right lead.The outer coil on the left lead was stretched out between the terminal pin and tubing around the lead serial number label, but it still showed good connectivity with an impedance of 377.To reinforce this section of the lead, dr.(b)(6) put a tube around this portion and filled it with silicone adhesive.The final impedance for the left lead was 376.The patient had not been experiencing any symptoms leading up to the ipg replacement and lead repairs.
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Search Alerts/Recalls
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