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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS Back to Search Results
Model Number B35200
Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Dysphasia (2195); Cognitive Changes (2551); Unspecified Nervous System Problem (4426)
Event Type  Injury  
Event Description
It was reported that the patient (pt) tried to commit suicide about 2 weeks ago.The manufacturer's representative (rep) reports the leads seem not optimally placed and the pt is not getting the symptom relief they were hoping for.The rep did not know when this all started.The rep reported the healthcare provider (hcp) has ordered a ct scan and will look at the lead placement, unknown if surgery is required, will determine after reviewing the ct scan.The pt is scheduled for reprogramming, the rep reports they will be at that appointment, (b)(6) 2022.The rep will try to reprogram to provide symptom relief to patient with different programming, possible double monopolar.Troubleshooting was unable to be performed as not with patient.
 
Manufacturer Narrative
Other relevant device(s) are: product id: b3300542, serial/lot #: (b)(4), ubd: 02-feb-2024, udi#: (b)(4); product id: b3300542m, serial/lot #: (b)(4), ubd: 10-nov-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from manufacturer representative (rep) that they were the patient¿s initial lead placement.Patient had very little recording on the mer recording as determined by specialty care.Per rep, patient also had no symptoms to test in the operating room (or) other than some mild foot dystonia that he said was unrelated to his parkinson's disease (pd), patient had no tremor in the or.The hcp who did his initial programming said she got tremor suppression in his foot at higher amplitudes but did cause some mild dysarthria.The hcp sent the patient for a second opinion.The surgeon did not want to move the lead and wanted to just implant at that location regardless of lack of recording and testing.The rep states this is not a fault of medtronic personnel, equipment or implants.The rep reports the cause of the cortical intraparenchymal hemorrhage and the leads not being optimally placed is unknown.The physician ordered a stereotactic ct for this patient and made calculations.The nurse practitioner (np) stated that physician conveyed to her that the lead appeared to be off by several millimeters.Need for potential surgical intervention is to be determined though hcp conveyed to the patient that he is going to need another surgery for the optimal placement of the leads.The patient conveyed that they never really got any symptom relief after the dbs surgery despite multiple programming sessions.Np worked on programming trying different configurations/modes again.Rep plans to follow up with np and physician.
 
Manufacturer Narrative
Continuation of d10: product id b3300542 lot# serial# (b)(6) product type lead product id b3300542m lot# serial# (b)(6) 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.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 d10: product id b3300542 lot# serial# (b)(6) implanted: explanted: product type lead product id b3300542m lot# serial# (b)(6) implanted: 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.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 from the manufacturer's representative (rep) who reported that there was a cortical intraparench ymal hemorrhage in the left side for this patient.
 
Manufacturer Narrative
Continuation of d10: product id b3300542 lot# serial# (b)(6).Product type lead product id b3300542m lot# serial# (b)(6).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.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 from the manufacturer's representative (rep) who reported that the np (nurse practitioner) is go ing to see the patient again for reprogramming on july 25th.During the last programming session, the np tried programming and stated they were able to get some symptoms relief for the patient by stimulating 0- 1- contacts.The rep will be at the next appointment.
 
Manufacturer Narrative
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 from the rep.The hcp has offered to have the patient undergo a lead revision and there has been no further communication from the patient at this time.
 
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Brand Name
PERCEPT
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key15066901
MDR Text Key296245073
Report Number3004209178-2022-09236
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00763000420987
UDI-Public00763000420987
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/28/2023
Device Model NumberB35200
Device Catalogue NumberB35200
Was Device Available for Evaluation? No
Date Manufacturer Received10/04/2022
Date Device Manufactured11/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
"SEE H10...."
Patient Outcome(s) Other;
Patient SexMale
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