MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number NEU_INS_STIMULATOR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Therapeutic Effects, Unexpected (2099); Visual Impairment (2138); Dysphasia (2195); Shaking/Tremors (2515)
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Event Type
Injury
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Event Description
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It was reported the patient ¿seemed sleepy, struggled to open his eyes,¿ had slowed and mumbled speech, and increased tremor frequency and severity.The patient was ¿in intensive care¿ at the time of report.The patient¿s physician indicated ¿the patient had a hemorrhage at the lead tip and at the entry point of the lead.¿ it was unknown when the event had occurred; however, the issue was noted to have been found on a post-operative ct scan that was performed either the afternoon of or morning after implant.It was noted there were ¿no vessels¿ found during ¿stealth¿ imagine in either location.The cause of the issue remained undetermined at the time of report.The patient was alive ¿with injury¿ and had ¿no improvement¿ in their symptoms at the time of initial report.Some reprogramming was performed with the patient as a result, though ¿no clinically significant benefit¿ had been attained as of three days after initial report.The patient was ¿unwell¿ and continued to have ¿slurred speech, poor eyes, and bad tremor¿ as of three days after initial report.It was stated the ¿true benefit was unknown¿ at that time.It was "unknown" whether any interventions had been required due to the event.Additional information was requested; a supplemental report will be filed if additional information is received.
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Manufacturer Narrative
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Concomitant product: product id 3389-40, lot # va0pc08, implanted: (b)(6) 2015, product type lead.(b)(4).
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Search Alerts/Recalls
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