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Model Number 3186 |
Device Problems
Fracture (1260); High impedance (1291)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete event and device information.The lead is believed to be either an octrode or a quattrode.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported the patient was undergoing an ipg replacement on (b)(6) 2020.During the procedure, the physician removed the ipg, and the lead came out of the ipg header automatically without any pressure.When the lead from the 9-16 port came out of the header, and the tip of the lead appeared ¿chipped¿ and the integrity of the lead appeared compromised.When impedances were measured, one electrode was high.Effective therapy was achieved during postoperative programming, and no further intervention is planned.
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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.Additional information: model number, brand name, lot number, device expiration date, udi, implant date and device manufacture date.
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Search Alerts/Recalls
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