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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MDT SOFAMOR DANEK PUERTO RICO MFG ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7425
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Sepsis (2067)
Event Date 09/01/2003
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer regarding the patient. It was reported that in regards to the date that the spinal cord stimulation device came out and the type of infection that she had, all she knows is that she was septic and does not know the day the device was explanted. She went to the emergency room for 3 visits 10 days prior and they kept telling her that everything was fine, and the next thing that she knew, they told her that she had to come in right away because she was septic. She was hospitalized for 10 days. The hospital never returned the product. There were no further complications reported or anticipated.
 
Event Description
Information was received from a patient with an implantable neurostimulator (ins) for complex regular pain syndrome type i. The patient reported having an infection and redness. Their nerve stimulator was infected and by (b)(6) 2003 they were septic. The infection was confirmed. The patient had a total system explant, they were in the hospital, and were on iv antibiotics for 2 weeks. The patient fully recovered from the infection. No further complications were reported/are anticipated.
 
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Brand NameITREL 3
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7014912
MDR Text Key100939913
Report Number1030489-2017-02287
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2004
Device Model Number7425
Device Catalogue Number7425
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 Received11/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/06/2003
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: 11/09/2017 Patient Sequence Number: 1
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