ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG
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Model Number 3660 |
Device Problems
Vibration (1674); Temperature Problem (3022); Noise, Audible (3273)
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Patient Problems
Burning Sensation (2146); Discomfort (2330)
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Event Date 09/25/2020 |
Event Type
Injury
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain event information.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 that during an mri on (b)(6) 2020, the patient experienced a vibrating sensation, burning, and noises from the ipg site.As a result, the mri was aborted.Surgery may occur to address the issue.
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Manufacturer Narrative
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The event of vibration during mri was reported to abbott.During an mri, the patient experienced a vibrating sensation, burning, and noises from the ipg site.As a result, the mri was aborted.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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