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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 Electromagnetic Compatibility Problem (2927)
Patient Problems Hypoventilation (1916); Pain (1994); Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Tingling (2171); Anxiety (2328); Complaint, Ill-Defined (2331); Irritability (2421); Sweating (2444); Diaphoresis (2452); Sleep Dysfunction (2517); Cognitive Changes (2551); Weight Changes (2607); No Code Available (3191); Paresthesia (4421); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/27/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that that over the last few months, the patient's neurostimulator (ins) was being affected by external interference from phones and computers other electrical devices. The patient gets an increased buzzing and tingling in his spine that travels to his head and ears. If he keeps the stimulator on for more than 4 hours, it¿s because too unbearable to keep on. The patient noted he may lose his job because of the distraction and change in his mental state. The patient was seen for reprogramming and that didn't help. The patient was sent for a ct scan, which came back normal. The physician recommended turning the ins off for a month and taking medication to "calm the nerves down. " the patient didn't like that option due to the pain he was in when the ins was off. The patient stated that this issue started about 3 months ago; he started to hear radio signals. The patient clarified that it sounded like broadcasts or music and no one else but him could hear it. The patient thought it was the oral medications he was taking, but he stopped taking all oral medications but was still hearing ¿radio signal noise. ¿ the patient reported that on the day he was hearing the noise he had his cell phone near him. The patient held his phone to his ear and he could feel electric vibration in his body like nails down a chalk board. The patient could feel/hear the sensation like when you walk under a live electrical wire and hear the buzz and popping. The patient could feel that in his body. The patient noted that he was reprogrammed on (b)(6) 2020 and his therapy/ins had been off for about 5 days before the appointment. The patient turned the ins on and within an hour after turning the ins back on he was hearing and feeling the electrical noise again. The manufacturer¿s representative (rep) checked the ins and didn¿t find any problems with it. The rep turned stimulation on to adjust programming and the patient instantly felt the agitation in his body and he was sweating and the rep could see a physical change in his body with stimulation on.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10747709
MDR Text Key220189436
Report Number3004209178-2020-18811
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,Followup,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2021
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 Received01/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/24/2020
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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