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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problem Electromagnetic Interference (1194)
Patient Problems Chest Pain (1776); Pain (1994); Sepsis (2067); Therapeutic Effects, Unexpected (2099); Weakness (2145); Malaise (2359); Neck Pain (2433)
Event Date 09/21/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care provider reporting that a patient with an implantable neurostimulator (ins) was admitted to the hospital on (b)(6) with symptoms of weakness, low blood pressure, and elevated lactic levels. It was also reported that the patient was not feeling right and they had symptoms of possible sepsis. A full body mri was performed to see if the recent lead implant related to the infection (sepsis) symptoms. Shortly after the mri was completed and the patient turned the stimulation back on, the patient started to have sharp, shooting and excruciating pain that started in the patient's chest and continued into their neck and shoulders. They ruled out any cardiac problems. The pain was a lot more intense than patient was used to. The patient was feeling his stimulation during this time when he was having pain. The patient then turned off his stimulation and the pain subsided with time. Patient is now feeling his usual pain like he had before he has scs system. Indication for use is spinal pain.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key6044626
MDR Text Key101186725
Report Number3004209178-2016-22197
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2017
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/20/2016 Patient Sequence Number: 1
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