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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 Electromagnetic Interference (1194); Electromagnetic Compatibility Problem (2927)
Patient Problem Insufficient Information (4580)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The healthcare professional reported that the patient had an open mri a few years ago and the patient felt like his stimulator and lap band were "talking" to each other during the scan. The patient felt a "peculiar sensation" in his abdomen.

 
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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 Key12289161
MDR Text Key265431594
Report Number3004209178-2021-12033
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/06/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/14/2015
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 Received08/03/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/16/2014
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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