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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

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MEDTRONIC PUERTO RICO OPERATIONS CO. VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON Back to Search Results
Model Number 353101
Device Problems Therapy Delivered to Incorrect Body Area (1508); Environmental Compatibility Problem (2929)
Patient Problems Undesired Nerve Stimulation (1980); Burning Sensation (2146)
Event Date 10/30/2023
Event Type  malfunction  
Manufacturer Narrative
Continuation of d10: product id: 306001, implanted: (b)(6) 2023, product type: screening device; product id: 309201, implanted: (b)(6) 2023, product type: screening device.Section d information references the main component of the system.Other relevant device(s) are: product id: 306001, serial/lot #: unknown; product id: 309201, serial/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.
 
Event Description
Information was received from a trial patient who was using an external neurostimulator (ens) for urgency frequency.It was noted that the patient's trial started on (b)(6) 2023.It was reported that the patient was experiencing stimulation in the wrong location.Troubleshooting was not performed.The issue was caused by patient movement/activity/accident.This issue was on going.Additional information was received from the patient on 2023-oct-31.The patient reported that they had decreased the stimulation to 2.2 as they were having burning going down their leg the day before.Patient stated that on the day of their call they had some burning in their back and for a little while.They were advised to contact their clinician with concerns.
 
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Brand Name
VERIFY ENHANCED
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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 Key18120081
MDR Text Key328018562
Report Number3004209178-2023-20565
Device Sequence Number1
Product Code EZW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number353101
Device Catalogue Number353101
Was Device Available for Evaluation? No
Date Manufacturer Received10/30/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
"SEE H10...."
Patient Age70 YR
Patient SexFemale
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