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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 High impedance (1291); Impedance Problem (2950)
Patient Problems Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Date 01/20/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger. Product id: 97745bp, serial#: (b)(4), product type: accessory. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that on january 20, 2020, the patient was charging the ins when the controller stopped charging at 70% and saw a message to contact the manufacturer. They weren't able to charge the ins beyond 70% until after they waited a couple of hours. The rep didn't have any further details but stated they would contact the patient to obtain more information. No symptoms were reported. No further complications were reported or anticipated. Additional information was received from a manufacturer¿s representative (rep). The rep reported that the patient claimed that after getting to about 70% when recharging, he would get an error message not allowing him to charge any further. If the patient waited a few hours and tried again, then he could get the battery to 100%. The patient was instructed to make sure his controller was charged up before trying to charge his implant and if this continued then it may be a software issue in which he would need to contact patient services for a new controller. The rep reported that the cause was not 100% confirmed but would be monitored to determine if the recharging issues were related to the controller not being charged enough prior to recharging session or if it a software issue related to the controller. The patient was to follow up with the rep if he continued having these issues and the rep hadn't heard from the patient. No further complications were reported. Additional information was received from a consumer and a manufacturer representative and it was further reported that the patient had a charging issue due to the system problem, rm04 error code that persisted when trying to charge. The controller battery took a long time to charge up. The controller and the ins battery were always above 40%, they had reset the battery about 3 times, but otherwise they were able to clear it without resetting. They then reported that the patient had a serious pain issue on their side over the top of the device and intermittent therapy. They saw their doctor and a chiropractor three times. The caller thought that the pain was related to the difficulty charging they had. They noted that every time they had a recharging issue they felt the pain, like it was burning their skin. The patient compared it to an old tens unit and the burning feeling that would happen when it was low. The patient kept the ins and controller battery charged to at least 40% at all times. They noted that the back issue made it so they couldn't sleep at night and they were miserable working 40-50 hour weeks. The symptom occurs every time the patient had the recharging issues. The issue became worse and constant on (b)(6) 2020. They couldn't sit, stand, or lay. The manufacturer representative further reported that the patient had issues with recharging regarding heat at site, swelling, and tenderness over the area. The factors that may have led to the issue were unknown and the issue was not resolved at the time of the report. No further complications were reported or anticipated. Additional information was received and it was reported that the patient had pain at the battery site. They thought it was worse after recharging due to the paddle creating a lot of heat and getting an error message on the controller. They were sent a new controller and paddle and had not had the recharging issue, but the battery site pain was still there. They ran an impedance test and electrodes 4-7 and 12-15 were orange 'avoid'. They programmed around these for all 3 groups. The patient would follow-up with a healthcare provider if the battery site pain continued as it may not be device related. No further complications were reported or anticipated.
 
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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 Key10131297
MDR Text Key194535755
Report Number3004209178-2020-09925
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
Report Date 06/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2018
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 Received06/09/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/15/2017
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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