MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37612 |
Device Problems
Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Skin Discoloration (2074); Complaint, Ill-Defined (2331); Injury (2348)
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Event Date 02/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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Information references the main component of the system and other applicable components are: product id 3708660, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2020.Product type extension, product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2019.Product type extension, product id 3387s-40, lot# va04d32, implanted: (b)(6) 2012, explanted: (b)(6) 2020.Product type lead.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: it was reported that the patient¿s devices were removed due to infection.The hospital was unwilling to share the results due to privacy reasons and pathology unwilling to process devices further as they were removed for infection and no suspected malfunction.
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Manufacturer Narrative
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Information references the main component of the system and other applicable components are: : product id 3708660, serial# (b)(4) implanted: (b)(6) 2019, explanted: (b)(6) 2020.Product type extension, product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2019.Product type extension, product id 3387s-40, lot# va04d32, implanted: (b)(6) 2012, explanted: (b)(6) 2020.Product type lead.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 the patient stating that in (b)(6) 2019,one of the wires broke so the health care provider (hcp) did surgery and changed /replaced it.Patient was healed fine and then months later patient could feel the wires through their skin, it was discolored and after several months it was still getting worse.It was stated that on (b)(6) 2020, an exploratory surgery was done and decided to remove it.Patient was taking medication now.
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Manufacturer Narrative
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Concomitant medical products: product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2019, product type: extension.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 had possible erosion of the left deep brain stimulation (dbs) extension by their ear.Surgery was stated to be scheduled as "exploration of left post auricular wound with possible explant of all or part of dbs system." no environmental/external/patient factors that may have led or contributed to the issue were known at the time of reporting.No further information was known regarding troubleshooting or actions/interventions prior to exploration.The manufacturing representative (rep) stated they would obtain further information on (b)(6) 2020, the date scheduled for the exploratory procedure.Additional information was received on (b)(6)2020 that the hardware all was explanted.There were no known additional actions/interventions being taken to resolve the issue.It was stated the " left side scalp is exposed and possibly infected.All hardware was removed and sent to pathology for culture.".
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Search Alerts/Recalls
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