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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT
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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT Back to Search Results
Model Number B35200
Device Problems Break (1069); Intermittent Continuity (1121); Failure to Deliver Energy (1211); Pocket Stimulation (1463)
Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Neck Stiffness (2434); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/15/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: the event date is an estimated date.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient had a battery replacement from primary cell (pc) to percept on (b)(6) 2020 the patient is complaining that the implantable neurostimulator (ins) is turning off and on without making adjustment with the patient programmer (pp).About 6 months ago, the patient started having electrical sensations at the battery site.The patient did not report this as they thought it may be related to the ins nearing end of life.The usage information on the tablet showed that stimulation has not been turned off.The patient stated they have always had stiffness in the location of the extension/lead connection in their neck.They also have not felt the pinging or stimulation turning off sensation for a couple of days.Impedance values are all normal.The manufacturer representative (rep) inquired about what the issue may be and troubleshooting steps.Considerations were reviewed and they will follow up with the patient and physician.
 
Manufacturer Narrative
Section 'device' information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2016, product type: lead.Method code pertains to the lead, lot#: unknown.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative (rep) reporting they believe they found the issue.The patient's left brain lead was coming completely apart at the tip that connects into the extension.The physician tried their best to salvage it but they have no idea how their impedance check did not catch it.They will likely have to redo the cranial lead on the left side.
 
Manufacturer Narrative
H6.Device code c62973 pertains to the lead, lot # unknown.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.
 
Manufacturer Narrative
Continuation of d11: product id 37601 lot# serial# (b)(6), implanted: (b)(6) 2016,explanted: (b)(6) 2020, product type implantable neurostimulator product id neu_unknown_ext lot# serial# implanted: explanted: 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.
 
Event Description
Additional information was received that patient that felt the sensation a the battery site with both implants.The electrical sensation resolved, however, period cessation of therapy continues.Diagnostics and troubleshooting was performed related to the implant turning off/on and measurements and charts were within range.Palpation did not provide new information.After interrogation it is the physician and rep's theory that he extension may have some damage or cracking, but acknowledged that it is hard to tell.A replacement procedure has been scheduled for the extension and implanted percept device and will be returned for analysis.The active pc has been discarded.
 
Event Description
Additional information was received from a manufacturer representative (rep) reporting on (b)(6), the extension and percept was rem oved/replaced and on (b)(6), the cranial lead was removed/replaced.The patient is doing great now, so the cranial lead was determined the issue.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
Continuation of d11: product id 3389s-40 lot# unknown serial# implanted: (b)(6) 2016 explanted: product type lead product id 37601 lot# serial# (b)(6) implanted: (b)(6) 2016 explanted: (b)(6) 2020 product type implantable neurostimulator product id 3708660 lot# serial# (b)(6) implanted: explanted: product type extension product id 3708660 lot# serial# (b)(6) implanted: (b)(6) 2016 explanted: product type extension product id 3389s-40 lot# unknown serial# implanted: (b)(6) 2016 explanted: product type lead 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.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.
 
Manufacturer Narrative
H6.Fdc code pertains to the lead (lot #unknown).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.
 
Manufacturer Narrative
H3.Analysis of the ins (s/n: (b)(6)) revealed no anomaly.Analysis of the extension (s/n: (b)(6)) revealed the outer insulation of the extension body melted/no significant anomaly.Analysis of the extension (s/n: (b)(6)) revealed the outer insulation of the extension body was cut/no significant anomaly.Analysis of the lead (lot #: unknown) revealed insulation at the proximal end was broken under the connector.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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Brand Name
PERCEPT
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key10541187
MDR Text Key208123122
Report Number3004209178-2020-16061
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00763000253363
UDI-Public00763000253363
Combination Product (y/n)N
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/14/2022
Device Model NumberB35200
Device Catalogue NumberB35200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2020
Initial Date Manufacturer Received 09/15/2020
Initial Date FDA Received09/16/2020
Supplement Dates Manufacturer Received09/16/2020
09/24/2020
09/24/2020
10/16/2020
10/19/2020
02/02/2021
02/09/2021
Supplement Dates FDA Received09/18/2020
09/24/2020
09/24/2020
10/19/2020
10/20/2020
02/04/2021
02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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