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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 Intermittent Continuity (1121); Failure to Deliver Energy (1211); Battery Problem (2885)
Patient Problems Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517)
Event Date 06/07/2020
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 consumer regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that on (b)(6) 2020, the patient noticed the ins was running low because the stimulation was going faster/surges, which happens when they need to charge the ins again. The controller had a triangle displayed on the screen, but they couldn't read any other information on the screen because they didn't have their glasses on. When they started to recharge the controller screen was black, but they did see a green light on the charger/controller. The patient did try to plug the controller into the ac power supply but that didn't resolve the issue. They replaced the lithium-ion battery pack with aa batteries, but the controller didn't respond. Since the ins was dead and without stimulation on, the patient had a "rough night". During the call with patient services, the aa batteries were taken out of the controller, and the controller was then plugged into the ac power supply. The controller then powered up. After powering up, they were told to put the lithium battery back into the controller, which then allowed them to connect to the ins. It indicated the ins needed to be charged, so the patient started charging the ins with excellent recharge quality; issue was resolved. 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 Key10136059
MDR Text Key194648391
Report Number3004209178-2020-10006
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 06/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2018
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 Received06/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/07/2017
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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