Model Number 3186 |
Device Problem
High impedance (1291)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.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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Related manufacturer reference number: 3006705815-2020-30487.Patient initially reported error in setting ipg to mri mode.Troubleshooting was done and found high impedance on lead contacts.Reprogramming was done to obtain full therapy coverage however physician is planning to do a revision surgery in the future.
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Manufacturer Narrative
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Additional information: a4 - patient weight.
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Manufacturer Narrative
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Additional information: h6 - method code: 4117 has been updated to 4114.
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Event Description
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Additional information was received that surgery occurred during which the leads were explanted and replaced to address the issue.
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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.
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Search Alerts/Recalls
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