MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37601 |
Device Problems
Break (1069); High impedance (1291); Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Insufficient Information (4580)
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Event Date 11/16/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: other applicable components are: product id: 3389s-40, lot #: (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 3389s-40, lot #: (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 37085-60, serial #: (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 37085-60, serial #: (b)(4), implanted: (b)(6) 2012, product type: extension.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 13-jun-2014, udi#: (b)(4).Product id: 3389s-40, serial/lot #: (b)(4), ubd: 27-sep-2014, udi#: (b)(4).Product id: 37085-60, serial/lot #: (b)(4), ubd: 13-dec-2015, udi#: (b)(4).Product id: 37085-60, serial/lot #: (b)(4), ubd: 13-dec-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider (hcp)via manufacture representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for movement disorders.Return of symptoms was reported.No external or patient factors that may have contributed or led to the issue were reported.Impedance readings were out of range on all contacts on the right side.Due to elevated impedance readings, the patient¿s chest pocket was opened.The extensions appeared damaged with the insulation around the wires gone, and the bare wires exposed.The same was true for the leads, when the lead/extension connection was explored.The leads appeared brittle, and the wires were exposed.The doctor switched ports in the ipg, and elevated impedances switched as well, indicating the problem was either in the lead or the extension.The issue was not resolved at the time of the report.Physician chose to leave devices implanted, as the patient is still receiving some benefit; however, further surgical intervention is required.No further patient complications were reported/ anticipated as a result of this event.
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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 3389s-40 lot# v800515 serial# implanted: (b)(4) 2012 explanted: product type lead product id 3389s-40 lot# v911920 serial# implanted: (b)(4) 2012 explanted: product type lead product id 37085-60 lot# serial# (b)(4) implanted: (b)(4) 2012 explanted: product type extension product id 37085-60 lot# serial# (b)(4) implanted: (b)(4) 2012 explanted: 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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Additional information was received from a health care provider (hcp) stating that the cause of high impedances was issue found with broken leads-brittle/disintegrating insulation was seen at connection.
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Manufacturer Narrative
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Section 'device' information references the main component of the system and other applicable components are: product id: 3389s-40, lot# v800515, implanted: (b)(6) 2012, product type: lead; product id: 3389s-40, lot# v911920, implanted: (b)(6) 2012, product type: lead; product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, 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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Additional information was received: it was reported that a call was received from the patient on (b)(4) 2018.They stated the doctor checked on their whole dbs system on (b)(6) 2018 because of abnormal impedances.While checking the whole system the doctor found that the lead was brittle and was only scheduled for the replacement of the lead.The ipg, extensions other lead was removed.There were no further complications reported.
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Manufacturer Narrative
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H3.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 received from the healthcare provider (hcp) reported the device was replaced due to normal battery depletion.
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Manufacturer Narrative
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Product analysis #702879214:analysis information (b)(6) 2022, 10:32:45 cst pli# 90 product id# 37601 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.Continuation of d10: product id 3389s-40 lot# v800515 serial# impl anted: (b)(6) 2012,explanted: product type lead product id 3389s-40 lot# v911920 serial# implanted: (b)(6) 2012, explanted: product type lead product id 37085-60 lot# serial# (b)(6) ,implanted: (b)(6) 2012,explanted: product type extension product id 37085-60 lot# serial# (b)(6) ,implanted: (b)(6) 2012,explanted: product type extension h3: analysis of the implantable neurostimulator (b)(6) ,revealed the battery was functionally okay, no significant anomalies observed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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