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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Break (1069); Battery Problem (2885); Patient Device Interaction Problem (4001)
Patient Problems Burning Sensation (2146); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 26-oct-2021, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 26-oct-2021, udi#: (b)(4). The following products are reported in a separate regulatory report. See report #3004209178-2021-06703. Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead. Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead. Product id: 97715, serial#: (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator. 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) regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient has two systems implanted, cervical and thoracic. The patient stated hat her cervical implant has always caused her issues, specifically burning in her throat. She also reports having 4 grand mal seizures post nuss procedure. They believe this was caused by a new medication initiated post-procedure. The cervical was done after her seizures which shows electrodes on both leads that appear to be fractured. The rep attached an image for reference. The cervical ins was dead at the time of the report. The rep was unsure if the cervical lead issue happened before or after seizures but imaging post-seizure did show what appeared to be fractured leads. The patient wanted to have the cervical system explanted so they are planning to do that. Surgery was scheduled for (b)(6) 2021. The issue was not resolved at the time of the report.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key11731756
MDR Text Key247498994
Report Number3004209178-2021-06741
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
Type of Report Initial,Followup,Followup,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2018
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/05/2017
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: 04/27/2021 Patient Sequence Number: 1
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