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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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| Model Number B35200 |
| Device Problems
Break (1069); High impedance (1291); Application Program Problem (2880); Therapeutic or Diagnostic Output Failure (3023)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 10/19/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id b3300542m lot# va2f28jv12 serial# implanted: (b)(6)2021 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: b3300542m, serial/lot #: va2f28jv12, ubd: 06-jul-2023, udi#: (b)(4) 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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Information was received from a healthcare provider (hcp) regarding an implantable neurostimulator (ins).The reason for call was caller stated patient was seen on (b)(6)2022 and healthcare provider (hcp) noticed contact 9b (not active in programming) impedance was yellow.Today, patient was in office and stated they had been receiving an out of regulation message on their handset (unknown date as to when message started).Impedances were checked today at 0.4 ma and all were over 5k for monopolars and over 10k for bipolars, except for 8 and 10c, which were green.Hcp re-ran impedances at 1.0 ma and the high impedances were then orange and 8 and 10c remained in range.Caller stated patient came in with 10b programmed so hcp reprogrammed to use 10c and patient appeared to be getting stim.The caller was not with the patient.Caller was going to see patient tomorrow to run impedances again.Tss suggested running impedance with auto-algorithm, check impedance in different positions (patient turning head to left/right, etc.), obtaining imaging and seeing if patient has had any shocking sensations.Tech services (tss) reviewed if therapy can't be achieved using viable contact, likely they will need to go intra-op, perform lead-only impedance testing and determine which component needs to be replaced.No symptoms reported.Additional information was received from the manufacturer representative (rep).The cause of the high impedance issue was not determined.When run with automatic amplitude, all contacts on the b33005m lead were above 10k (range 14-38k) except contacts 8 and 10c.Impedance measurements were verified by the representative.The high impedance issue was not resolved.This information was confirmed with the account and no additional information is available at this time.
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Event Description
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Additional information was received from a hcp via a rep reporting that impedance test showed open circuit on all contacts for the right lead.Values were over 5k for all monopolar pairs and over 10k for all bipolar pairs.Impedance check was performed at 1ma and then re-ran with automatic increase.The patient was referred to a surgeon for x-rays and potential surgical intervention.
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Manufacturer Narrative
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D10: section d information references the main component of the system.Other relevant device(s) are: d10: product id: b3300542m, serial# (b)(6), implanted: (b)(6) 2021, product type: lead.Product id: b3400060m, serial# (b)(6), implanted: (b)(6) 2021, product type: extension.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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Manufacturer Narrative
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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 manufacturer¿s representative (rep) reported the referral to the surgeon hadn¿t taken place yet.The neurologist was ordering x-rays of the chest, neck, and head, but the results hadn¿t been shared yet.
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Manufacturer Narrative
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H3.Analysis of the lead (s/n (b)(6) ) found the conductor was broken with 10 centimeters of the connector area.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information received from the manufacturer¿s representative (rep) reported the patient underwent right lead revision.When the replacement lead was tested prior to connecting to the extension, all impedances were normal.After connection to the right extension (that was already connected to the implant) all impedances were normal except 10c and any bipolar pair with 10c (impedances were all 10,000 ohms).The original lead was being sent back for analysis.The surgeon noted that at the time of the removal it appeared the lead insulation was missing where the lead exited the burr hole clip.
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Manufacturer Narrative
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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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