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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97725
Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Complaint, Ill-Defined (2331); Nipple Ulceration (2441); Skin Inflammation (2443); Alteration In Body Temperature (2682); Fluid Discharge (2686); Test Result (2695)
Event Date 07/17/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant product(s): product id: 977d260, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: screening device. Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 06-jun-2022, udi#: (b)(4). Initial reporter's occupation: non-healthcare professional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturing representative (rep) regarding a patient with an external neuro stimulator (ens). It was reported that patient had possible infection. Lead was removed at hospital er. Patient has psoriasis and sterile coverage/ bandage kept falling off that may have led or contributed to the issue. Patient was admitted to hospital. Lead pulled at hospital and patient admitted. Rep indicated to contact health care professional (hcp) for further information. Rep further explained that during a mid-trial phone follow up patient stated he may have an infection, said it was red and warm at the lead sight butnotiozing and no fever. Rep instructed patient go to the er if he felt it was and patient told rep he would think about it. Patient made a comment that he could lance it. Rep told him he needed to go to the er. Patient called the health care professional (hcp) the next morning and hcp told him to come in. Patient said he did not want to drive. Hcp prescribed antibiotic keflex which he took one dose of. That night rep was notified that patient went to the er and was admitted with fever, oozing from lead site and elevated white count. Lead was removed and patient was being treated at hospital. No further patient symptoms or complications were reported in this event.
 
Manufacturer Narrative
Other applicable components are: product id: 977d260, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: screening device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the representative. It was reported that the patient hadn't responded to the clinic yet so they didn't know if the patient's symptoms resolved but they had an upcoming appointment at the clinic. No further complications reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameINTELLIS
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 Key7707895
MDR Text Key114671236
Report Number3007566237-2018-02176
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
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,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/15/2019
Device Model Number97725
Device Catalogue Number97725
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/30/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/20/2018 Patient Sequence Number: 1
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