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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS Back to Search Results
Model Number 37601
Device Problems Break (1069); Impedance Problem (2950); Positioning Problem (3009)
Patient Problems Fall (1848); Dyskinesia (2363); Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: 3708640, serial/lot #: (b)(6), ubd: 06-feb-2023, 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
It was reported that the patient kept falling every time the implantable neurostimulator (ins) was turned on.Agent did not ask about the circumstances that led to the reported issue.The caller stated that the patient had an appointment with their physician who added a c or d setting that was much lower.The caller stated that the new setting did help a little but the patient was still tripping a lot.The caller noted that one of the patient's feet looked almost like it was dragging a little bit.The caller stated that the new setting unfortunately did not provide the patient with enough stimulation to control their dyskinesia.The caller mentioned that the only setting that helped with the patient's dyskinesia was the one that was causing them to fall.Patient went back to their physician for an ultrasound a misfire with one of the wires was observed.After that, the caller stated that the patient had surgery and the physician noticed there wasn't any insulation that had been put around the wire when it was implanted.The physician thought that might be why the fraying happened with the wire.The physician thought the wire was not implanted properly and might have been implanted a little more posterial.The wire was replaced.Caller confirmed they were referring to an extension that was replaced on (b)(6) 2022.
 
Event Description
Additional information received from the manufacturer¿s representative (rep) reported the patient was seen to have the extension replaced to try and resolve an out-of-range impedance on contact 2 (impedance values were unknown at this time).Once the extension was replaced the out-of-range impedance on contact 2 resolved.Before closing the incision, the physician noticed the insulation on the lead was compromised and although there were no issues on the patient¿s right system, they added some more medical adhesive to try and protect the small area that had exposed wires; it was unknown why the insulation was compromised.The extension was exposed of and thus wouldn¿t be returned.The patient¿s current condition was unknown.
 
Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id 3387s-40 lot# serial# (b)(6), implanted: explanted: product type lead product id 3708640 lot# serial# (b)(6), implanted:(b)(6) 2019, 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.
 
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Brand Name
ACTIVA
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 Key17958024
MDR Text Key325955344
Report Number3004209178-2023-17847
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00763000175719
UDI-Public00763000175719
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 Other
Type of Report Initial,Followup
Report Date 11/28/2023
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 Date08/28/2020
Device Model Number37601
Device Catalogue Number37601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/13/2023
Initial Date FDA Received10/18/2023
Supplement Dates Manufacturer Received11/21/2023
Supplement Dates FDA Received11/28/2023
Date Device Manufactured03/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
"SEE H10...."
Patient Outcome(s) Required Intervention;
Patient SexMale
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