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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 PARKINSONIAN TREMOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number B35200
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Distress (2329); Electric Shock (2554)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that there was a change made to the patients programming and since then, every time she tries to make a change with the stimulation she gets shocked where one of the leads is located in her head.The rep asked when this started to happen but the patient was in such distress that she was challenging to understand and the rep could not understand the patient's answer.The rep had linked the previous and current implants as the caller was not clear on if this issue of the shocking sensation was isolated to only the current ins or if this issue started on the previous ins and continued with the new ins.The patient was redirected to follow up with her hcp and the patient stated that she was trying to get an appointment with her surgeon hcp as the physicians assistants were not willing to do anymore programming and thought that the ins needed to be replaced.The rep offered to reach out to the medt ronic field rep on the patients behalf as her ins has not been checked and she is needing assistance.No further complications was reported.
 
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Brand Name
PERCEPT
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11638275
MDR Text Key266426427
Report Number3004209178-2021-05737
Device Sequence Number1
Product Code MHY
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/08/2021
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
Initial Date Manufacturer Received 03/29/2021
Initial Date FDA Received04/08/2021
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
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