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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 Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Anxiety (2328); Electric Shock (2554)
Event Date 07/04/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that there was an issue reported by a nurse where the patient was experiencing some troubles in communication between his ins and patient controller. The patient controller had difficulties detecting the ins. The issue had been happening for three to four months. The patient always had to re-pair his controller with the ins by using the recharger antenna. The problem was the same with another patient controller. A recharger/ins issue was noted. Additional information was received from the rep. It was reported that the patient did not experience a fall/trauma prior to seeing this error. It was not possible that the ins had moved/shifted. It was noted that the ins could be palpated and was sufficiently charged. The rep was to ask the nurse what screen the patient saw when trying to connect the controller to the ins. Additional information was received from the rep. It was reported that the ins was interrogated with the clinician tablet without any trouble. The patient tried with another patient controller and tried to move his own position (lying back, sitting, et cetera). The rep asked for interferences, but the patient didn't describe any modification to his environment since three months. Additional information was received from the rep. It was reported that the nurse told the rep that her tablet displayed an error message three times when communicating with the ins. The error was a system error with code 0x8bf3b3e. Additional information was received from the rep. A photograph showing the patient controller displaying screen number 16 was provided. It was reported that the error message had only appeared when communicating with the ins. The rep was to ask the nurse to extract the logs when back in this center. It was noted that moving the controller or changing position did not seem to fix the problem. Additional information was received from the rep. They were reaching out to the nurse to check how often the patient charged his ins. It was noted that if the patient was using high dose (hd) parameters, that may explain a low ins battery. Disabling/enabling the ins was discussed in case the battery was not depleted or almost deplete d. Additional information was received from the rep. It was reported that the ins implant date, ins serial number, and recharger serial number were unknown. The patient had two patient controllers since they tried replacing out to exclude a patient controller issue. Both controller serial numbers were provided. Replacement of the patient controller, moving the patient controller, changing the position of the patient, and repairing the patient controller and ins were all tried as troubleshooting. The cause of the event was unknown. It was noted that the patient's age and weight were unknown. Additional information was received from the rep. The serial number and implant date of the ins were provided. Additional information was received from the manufacturer representative (rep). It was reported that the patient was charging every 8-8. 5 days. It was unknown whether disabling and enabling the ins resolved the issue. The software version of the clinician app was provided. It was reported that logs were unavailable. It was further reported that the nurse had been contacted by the patient. After disabling/enabling the ins, the issue did not occur for 15 days. The communication issue between the patient controller and ins re-occurred during the christmas holidays. The stimulation was felt too strong. The patient experienced a jolting sensation after the last communication between the ins and patient programmer because the communication was lost and the patient could not decrease the amplitude immediately. The patient was afraid of it happening again, so he switched the therapy off. Painful symptoms were coming back. The patient did not describe any charge issue. The coupling was excellent, and the ins has never been discharged or on low battery level. The issue does not happen during a charge session. The ins was always charged. Additional information was received from the manufacturer representative reporting that only screen 16 displayed. When the issue happened, the patient tried to restore the communication by using the antenna of the charger such as a ¿reappearing¿ handling. The nurse replaced for the third time both the patient controller and recharger on (b)(6) 2021, unfortunately without any success, the issue happened again. It was noted that the ins was implanted in the left abdominal side. An x-ray was performed showing the ins was flipped. The cause of the ins flipping was unknown. The surgeon tried to return the ins without a revision but was unsuccessful. It was too painful for the patient even with meopa gas. The patient will be planned for a revision.
 
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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 Key11287060
MDR Text Key230523433
Report Number3004209178-2021-02081
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/05/2021 Patient Sequence Number: 1
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