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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MPRI SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number B3300542M
Device Problem Positioning Problem (3009)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 11/16/2022
Event Type  Injury  
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
It was reported that it was reported that, during the stage 1 implant, it was noticed after the oarm spin that the lead was about 20 mm posterior to where the planned target was.The physician rechecked the plan on the stealth as well as the frame coordinates, and did not find any abnormalities.Thus, the physician moved the y frame coordinate 20 mm anterior and the subsequent oarm spin confirmed that the lead was then at the planned target.After implanting the right lead, the oarm spin showed that the lead was about 4.5 mm lateral from the planned target.The physician thus moved the frame coordinates 4.5 mm lateral and the subsequent spin confirmed the lead was then at our planned target.The patient had a small intercranial hemorrhage.Physician stated the patient should be fine.Rep and physician contacted several individuals and tried to confirm where the error could be or if it was a stealth issue but nothing was conclusive.
 
Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id b3300542 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 received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the patient was doing fine and the generator was implanted on (b)(6).
 
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Brand Name
SENSIGHT
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba,pr MN 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
villalba,pr MN 00766
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key15855371
MDR Text Key304221212
Report Number2182207-2022-02202
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00763000426408
UDI-Public00763000426408
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/30/2022
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 Model NumberB3300542M
Device Catalogue NumberB3300542M
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/17/2022
Initial Date FDA Received11/23/2022
Supplement Dates Manufacturer Received11/29/2022
Supplement Dates FDA Received11/30/2022
Date Device Manufactured09/06/2022
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) Hospitalization;
Patient Age64 YR
Patient SexFemale
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