MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37603 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Fatigue (1849); Muscle Spasm(s) (1966); Complaint, Ill-Defined (2331); Cognitive Changes (2551); Electric Shock (2554)
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Event Date 01/21/2016 |
Event Type
Injury
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Event Description
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Information received from a clinical patient reported the patient experienced a stroke after the physician turned their device on/off on (b)(6) 2015.The physician was ¿turning the stimulation on and then it gave [the patient] a stroke, not they didn't turn it on they turned [the device] off and they gave [the patient] a stroke.¿ indications for use included dystonia and movement disorders.
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Manufacturer Narrative
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Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: implantable neurostimulator.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep).It was reported that the health care provider (hcp) has no records or knowledge regarding an appointment on (b)(6) 2015.It was noted however, that the patient had a visit on (b)(6) 2016 and reported that on the day prior, the patient and their spouse were adjusting the deep brain stimulation (dbs) and it caused a spasm in the patient's left arm and face that lasted for about 45 seconds before completely resolving.There was some concern that this represented a stroke or tia, but it occurred precisely at the time that the dbs was restarted.An mri of the patient's brain was performed, but no abnormalities were found.The hcp's assessment/synopsis was noted as: the patient's nih stroke scale/score (nissh) was very low, their symptoms are rapidly improving and their neurologic exam is more consistent with alcohol than stroke.The hcp also noted that they would check urine drug screen (uds) and ethyl alcohol (etoh) levels as the patient appeared intoxicated.A ct scan of the patient's head and a ct perfusion were performed and showed an unrelated long segment of complete occlusion of the right vertebral artery with reconstitution as well as apparent perfusion defect involving the left anterior mca territory surrounding the brain stimulator, which could be artificial.The final diagnosis included an altered mental status and alcohol intoxication.The patient's discharge diagnosis on (b)(6) 2016 included "altered mental status, resolved".Another follow-up appointment was conducted on (b)(6) 2016 where the patient presented with two spells.The first spell was related to deep brain stimulation (dbs) in that when the device is suddenly turned on, the patient gets a "jolt" and "can have drawing of the face".The hcp stated that they feel this is expected and is not indicative of tia.The second spell was noted to be likely related to the alcohol, fatigue, and a fall; the hsp did not think either spell was a tia or stroke.However, the hcp noted that they thought the new vertebral artery occlusion was most likely due to an unrelated atherosclerosis, as there was "some plaque seen at the origin of vert on the right and then is occluded".The hcp thought the patient was at risk for stroke and felt that the patient should continue asa and statin.The patient's medical history included: hyperlipidemia, bipolar, and pseudoseizures and dystonia.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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