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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 Unintended Collision (1429); Energy Output Problem (1431); Appropriate Term/Code Not Available (3191)
Patient Problems Fall (1848); Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
Occupation: non-healthcare professional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient and manufacturing representative (rep) regarding the patient's implantable neurostimulator (ins). Information was reported that the patient said their stimulation is not helping with their pain like it was post implant. The patient said she tripped and fell and "android correlates with the decrease in effectiveness". The patient has an appointment with the rep on (b)(6) 2018 to try to reprogram and get a possible x-ray. No further complications were reported. No patient symptoms were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the rep reported that the statement "android correlates with the decrease in effectiveness" that was previously reported must have auto-correct and that they did not know what they were trying to say. The patient clarified that they never felt stimulation in their legs, and only in their back. The stimulation was still helping the patient's back just fine. Reprogramming did not help with the patient's leg pain and it was reviewed with the patient that leg relief was an unrealistic expectation considering that they never even felt leg relief during the trial. No further complications were 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 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 Key7743308
MDR Text Key116403614
Report Number3004209178-2018-17262
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 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2019
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 Manufactured05/30/2018
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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