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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 Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Patient Device Interaction Problem (4001)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Inadequate Pain Relief (2388); Paresthesia (4421)
Event Date 10/02/2020
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) who was implanted with an implantable neurostimulator (ins). Information was received from a patient (pt) regarding an implantable neurostimulator (ins). Pt reported since implanted therapy had not really helped him, maybe 50% when he was standing or sitting down and he also had problems with laying down. Pt said he had been having problems from the pain level point. Over the last week or so he increased intensity for sitting and standing to 5-5. 5 on all 4 settings in group a. Pt said he was trying to get his laying down intensity to zero because he had no pain at all when he lays down on his back. When he increased settings to 5-5. 5-that helps his back pain a lot and he gets relief but he also gets a large amount of tingling in his legs. Pt said he had been getting vibrations on his legs all the time. Pt wants to keep his settings at 5-5. 5 but not feel vibration in his legs and have settings at zero in lying position. Pt also mentioned when he gets in his car the stimulation goes up because it is picking up signals from the car. Pt also noted the charge did not last for the whole day after he increased. Pt would like to work with a manufacturing representative (rep) on reprogramming. Redirected to healthcare provider (hcp).
 
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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
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 Key11716881
MDR Text Key267431433
Report Number3004209178-2021-06581
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,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2021
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 Received06/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/28/2020
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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