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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Fever (1858); Pain (1994); Sepsis (2067); Post Operative Wound Infection (2446)
Event Type  Injury  
Event Description
Information was received from a manufacturer representative (rep) via a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for non-malignant pain. The patient¿s medical history includes being a smoker, being overweight, and having sleep apnea. The patient had infection symptoms including redness, pain, and a fever so the hcp explanted the entire system on (b)(6) 2017. The cause remains unknown and no diagnostic studies were performed. The product would be replaced in the future. The patient is currently being treated at the hospital. They were admitted to the hospital for the infection at the pocket site and is septic at the time of the report. The issue is not yet resolved but the patient was noted to be alive with no injury. No further complications were reported/are anticipated.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6962239
MDR Text Key89742752
Report Number3004209178-2017-22157
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/14/2018
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/19/2017
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: 10/19/2017 Patient Sequence Number: 1
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