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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 Migration or Expulsion of Device (1395); Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2024
Event Type  Injury  
Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id 3389s-40 (lot: va1lyvk); product type: 0200-lead; implant date (b)(6) 2018, brand name sensight; product id b32000 (serial: unknown); product type: 0001-accessory.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
It was reported that patient (pt)  has exposed burrhole and lead on the right side of the head.Circumstances to event were unknown. patient met with the doctor and discussed the removal process.It is up to the patient if they will remove the dbs.The issue was not resolved.No symptoms reported.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
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.
 
Event Description
Additional information received from the manufacturer¿s representative (rep) reported the cause of the exposed burrhole and lead wasn¿t determined but could have been related to natural causes.The patient saw their neurosurgeon and was now deciding whether they wanted to remove the system or not.
 
Manufacturer Narrative
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Additional information was received from a consumer who reported the patient was currently very close to dying and was in the hospital.The patient ended up in the hospital because the lead "explanted" itself out of the top of the patient's head and had broken through the skin and the patient would not be able to survive that (patient is not deceased currently).The consumer mentioned they had always seen the pt with the little (lead) cap exposed and always thought that was normal.Pt rep said the lead cap had been exposed for probably 5 years, probably almost as soon as the pt got home for the initial dbs surgery.Sometime in (b)(6) 2024 the lead cap must've started moving because the actual lead wire became exposed.According to the consumer the cap had always been exposed so the pt's body had always fought off whatever infection might have happened but when the hcp saw the lead wire was exposed the neurologist said that shouldn't happen.Pt rep said that they had an in person consult with their physician and a manufacturer¿s representative (rep) on (b)(6), 2024 with a mdt rep.The consumer said the hcp told them that given the pt's age which was 86 years old and the pt hadn't had problems with it the risks of surgery were very high.The hcp said they thought the pt would need very expensive plastic surgery to get the scalp to cover the hole so hcp and pt rep agreed that to just leave the lead be how it was for the time being.Maybe a month later the lead just popped straight out and off the pt's head and the pt has been in the hospital ever since.The lead wire moved and caused pt seizures and brain damage.Pt rep said they want telemetry done on the dbs implant once it was explanted to know when the dbs was turned off.
 
Event Description
Additional information received from the consumer reported the patient passed away on(b)(6), 2024.The consumer wanted to know if anyone read the device.
 
Manufacturer Narrative
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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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 Key18875149
MDR Text Key337744481
Report Number3004209178-2024-06761
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00763000642174
UDI-Public00763000642174
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 Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberB35200
Device Catalogue NumberB35200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2024
Date Device Manufactured02/09/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Other; Required Intervention; Hospitalization;
Patient Age86 YR
Patient SexMale
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