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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VANTA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. VANTA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 977006
Device Problems Failure to Deliver Energy (1211); High impedance (1291); Appropriate Term/Code Not Available (3191)
Patient Problem Discomfort (2330)
Event Date 07/13/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that patient recently had implant and this new device was in the middle of their back. They said "they had to move it up in my back more, its a little uncomfortable, its gonna take some time to get used to. Patient reported they talked to their rep setting up a time to meet so they can do programming, and right when they were done talking to rep everything went off".   pt says their stimulation is what turned off and it happened when the pt was laying down, and wasn't sitting. Patient reported system error screen as well and this gave a code of: 0x53a58026 but says they were able to connect with implant again after seeing the code. Troubleshooting was unable to be performed as asked if pt has tried any other settings, and they said they have 3 different groups and only 1 setting on each group and have already tried all settings. The patient was redirected to their healthcare provider to further address the issue.   refer to (b)(4) for lead issues and (b)(4) for ins dying and was replaced.

 
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Brand NameVANTA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12325711
MDR Text Key266704407
Report Number3004209178-2021-12438
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number977006
Device Catalogue Number977006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/19/2021
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/16/2021 Patient Sequence Number: 1
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