MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37612 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Intracranial Hemorrhage (1891); Weakness (2145)
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Event Date 12/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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Other applicable components are: product id :3708660, serial#: (b)(4), implanted: (b)(6) 2013, product type: extension.Please note this report is in conjunction with regulatory report 6000153-2020-00006 and all further information will be continued in this regulatory report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient needed an mri of the head stating the hcp was unaware of the patient having a brain bleed or minor stroke, and ¿things had gotten worse¿ and was ¿weak on one side.¿ the patient stated the event was unrelated to the mri, but hcp was unsure of the root cause of the incident.The patient stated the dbs was implanted to trigeminal neuralgia.The patient mentioned they worked with the doctor but moved and was unsure of who took their place.It was recommended for the patient to call the previous managing doctor for assistance in filling out the mri form.The patient wanted to find an hcp closer but couldn¿t find a managing physician for their indication.
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Search Alerts/Recalls
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