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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problems Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
Patient Problem Dizziness (2194)
Event Date 07/29/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins). The reason for call was pt reported they quit charging their implant shortly after they were implanted because about 3 months after implant, they started getting dizzy and their healthcare provider (hcp) didn't know the cause of it. Pt could not confirm a date of when they stopped using the device. They stated it was shortly after they were implanted. Patient services (ps) suspects possible over discharge. Pt is interested in having the device restarted because they now need an mri and were told they cannot have an mri unless the device is able to be put into mri mode. Pt was redirected to their hcp to address possible over discharge. Addition information was received from the manufacturer representative (rep) and it was reported rep came to meet the pt (b)(6) 2021 at the mri appointment to activate mri mode as pt lost her controller. Caller reported end of service (eos) when she interrogated pt's ins.

 
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Brand NameSURESCAN
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 Key12359624
MDR Text Key267868945
Report Number3004209178-2021-12836
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 09/17/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/14/2017
Device MODEL Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/20/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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