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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Patient Device Interaction Problem (4001)
Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991)
Event Date 05/09/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins). The reason for call was since sunday the patient's stimulation increased when they coughed, sneezed, or laid on their back going down legs. The patient denied any traumas, falls, or heavy lifting. Patient services specialist verified that the patient's stimulation was on and turned up and their implantable neurostimulator was charged. The issue was not resolved. The patient went to the emergency room regarding this situation yesterday but they "couldn't do nothing about it". The patient was redirected to their healthcare provider to further address the issue. The patient mentioned unrelated medical history including patient had 3 surgeries on their legs (the last one being 4 months ago) and their right knee bothers them. The patient's spinal cord stimulator was implanted for sciatica issues.
 
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Brand NameINTELLIS
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11831838
MDR Text Key251948900
Report Number3004209178-2021-07786
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
Report Date 05/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2020
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/25/2019
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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