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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION 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 Unspecified Infection (1930); Skin Inflammation (2443)
Event Date 09/28/1999
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 patient via a manufacturer representative (rep) who was implanted with a neurostimulator for unknown indications. It was reported that the devices that were implanted in 1999 were removed shortly after they were implanted because the implantable neurostimulator (ins) got infected. The rep also noted that the patient developed a blister, so it was needed to be removed and was later replaced in 2000. There were no reports of device issues or allegations. There were no further complications reported or anticipated.
 
Manufacturer Narrative
Please note the event date is an approximation based on the year reported and the patient's implant date; only the event year is known at this time. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the rep noted the incident had occurred in 1999. There were no further complications reported or anticipated. The patient¿s indication for device use was other chronic/intractable pain (trunk/limbs).
 
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Brand NameITREL 3
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7428840
MDR Text Key105403210
Report Number3007566237-2018-01085
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received04/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/13/2018 Patient Sequence Number: 1
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