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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Intermittent Continuity (1121); Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Electric Shock (2554); Insufficient Information (4580)
Event Date 09/09/2021
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 via manufacturer representative who was implanted with an implantable neurostimulator (ins) for non-malignant pain. The reason for call was to ask about x-ray compatibility. The caller indicated that the patient contacted her because the patient had an xray and felt an increased stimulation sensation during that imaging procedure. The caller stated that patient is 6 weeks post-op and doing well with stimulation therapy. Troubleshooting was not required. Technical services reviewed i nformation about x-ray from the compatibility guideline document.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
MDR Report Key12481281
MDR Text Key271694437
Report Number3004209178-2021-13943
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 11/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/08/2021
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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