MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number B35200 |
Device Problems
High impedance (1291); Connection Problem (2900); Material Deformation (2976); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2023 |
Event Type
Injury
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Event Description
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The manufacturer representative (rep) reports patient was scheduled for stage 2 implant of the extension and implantable neurostimulator (ins).Caller reports the left lead was having impedance issue on the directional contacts 1 and 2, showing >5k ohms.Caller reports they perform the usual impedance troubleshooting, but did not resolve.When the physician attempted to load the lead into the extension port, it felt tight trying to get the lead in, the lead was not able to advance all the way in, the setscrew was not tight.The physician noted the end of the lead, was not ridge enough to apple pressure to advance the lead, caller reports the lead became kinked on the contacts.All the contacts were showing >5k ohms.Caller reports the kinked made it worse when physician tried to check the connection.No symptoms reported.
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Manufacturer Narrative
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Section d references the main component of the system.Other medical products in use during the event include: brand name sensight; product id b3301542m (lot: va2skr9v41); product type: 0200-lead; implant date (b)(6) 2023; explant date 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), which was confirmed with the healthcare provider, reported they were completing a bilateral stage 2 procedure when the hcp noted the connection site felt ¿tight¿ at the lead to extension connection.When they went to teste impedances, they were >5,000 ohms on 2 of 3 directional contacts on both contacts 1 and 2.It was the same 2 on both: 1b, 1c, 2b, 2c.Troubleshooting was performed, and they noticed there seemed to be some space between the grey collar-marker on the lead and the extension.The hcp said it felt tight and they checked that the set screw on the extension was not too far advanced, it was not.They disconnected and wiped the lead wet/dry and reconnected to the extension.They also tried flipping the extensions in the ins ports to be sure it wasn¿t the battery.There were no visible breaks or areas of concern.The hcp then requested trying a new extension which resulted in worse impedance across all contacts on the lead.The rep suggested testing the lead with a lead test cable, and they observed it was in fact the lead.The hcp noted there seemed to be a ¿kink¿ just past the contacts on the lead where the lead was bent from the pressure of being inserted into the extension.At this point the entire lead was now showing >10,000 ohms for all contact impedances.The hcp stated this must have been caused by the resistance he faced when inserting the lead into the extension and their continued efforts to correct the impedances which included several disconnections and reconnections which ultimately made the situation worse.A revision surgery was going to take place, but not yet scheduled.
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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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Manufacturer Narrative
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H3.Analysis of the lead (s/n (b)(6)) found the connectors were corroded on the proximal end of the lead.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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Manufacturer Narrative
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H3.Analysis of the lead (s/n (b)(6) found the connector on the proximal end was corroded.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 lead was damaged and removed on (b)(6).
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Manufacturer Narrative
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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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