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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 ESSENTI

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI Back to Search Results
Model Number B35200
Device Problems High impedance (1291); Unstable (1667)
Patient Problem Pain (1994)
Event Date 03/01/2023
Event Type  malfunction  
Event Description
It was reported that the patient felt neck pain and increased left-hand tremors after they bent over and felt their ipg almost "flip." hcp reported that the patient had impedance issues.  the hcp performed an impedance test with a clinician programmer.They found high impedances on multiple contacts.To resolve the issues, the hcp lowered stimulation to the affected side.It¿s unknown if the issue was resolved by the time of this report.The manufacturer representative (rep) requested the hcp the dbs session report from his interrogation.
 
Manufacturer Narrative
Concomitant medical products: product id 3708640 lot# serial# (b)(4) implanted: (b)(6) 2017 product type extension product id 3387s-40 lot# va1b8zj implanted: (b)(6) 2017 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3708640, serial/lot #: (b)(4), ubd: 14-may-2017, udi#: (b)(4) ; product id: 3387s-40, serial/lot #: (b)(4), ubd: 24-aug-2019, 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.
 
Event Description
Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the implant didn¿t flip; it almost flipped.Actual impedance values were unknown along with the cause of the impedance issue.It was unknown if the tremors and pain were resolved.The hcp was going to program around the high impedances and if that didn¿t help the patient achieve satisfactory therapy outcomes, they would refer them to their neurosurgeon to explore/resolve the impedance issue.
 
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.
 
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Brand Name
PERCEPT
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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 Key16483330
MDR Text Key310711703
Report Number3004209178-2023-03003
Device Sequence Number1
Product Code PJS
UDI-Device Identifier00763000253363
UDI-Public00763000253363
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/07/2023
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 Date07/28/2022
Device Model NumberB35200
Device Catalogue NumberB35200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2023
Initial Date FDA Received03/04/2023
Supplement Dates Manufacturer Received03/03/2023
Supplement Dates FDA Received03/07/2023
Date Device Manufactured08/04/2020
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 Age71 YR
Patient SexFemale
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