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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 Problem Human-Device Interface Problem (2949)
Patient Problems Nerve Damage (1979); Pain (1994); Weakness (2145)
Event Date 04/20/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead. Product id: 977a260, serial#: (b)(4), product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #:(b)(4), ubd: 12-jan-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer and a manufacturer representative regarding a patient with an implantable neurostimulator ( ins) for spinal pain. It was reported that there was nerve damage when the implant was done. The patient had pain and weakness in the left leg after implant. The physician was unable to implant the second lead and aborted. The physician prescribed steroid and pain medication for the patient post-op. The issue was reported to be resolved and the patient was feeling better and the leg was greatly improved. No further complications were reported.
 
Manufacturer Narrative
Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider. It was reported that the second lead was not implanted because the patient was experiencing pain and weakness, which was likely due to significant stenosis. No further complications are anticipated.
 
Manufacturer Narrative
Corrected information. 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 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7472425
MDR Text Key106872079
Report Number3004209178-2018-09577
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,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2019
Device Model Number97715
Device Catalogue Number97715
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 Manufactured03/20/2018
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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