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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Failure to Deliver Energy (1211); High impedance (1291); Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 04/06/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 3487a-33, lot#: unknown, product type: lead. Product id: 3487a-33, lot# :unknown. Product type: lead. Other relevant device(s) are: product id: 3487a-33, serial/lot #: unknown. Product id: 3487a-33, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported that the patient felt a slight heavier current than usual while changing position. Symptoms of chronic pain were returning slowly as the effectiveness of the stimulation was not given anymore which was a sudden change. No event occurred that contributed to the event, the patient was very fit and sporty. Troubleshooting was performed. The doctor performed a ¿radioscan¿. The scan showed that the leads moved and were not in the post-surgical positions anymore. Stimulation through other electrodes were not possible anymore. Impendences were bad, especially on electrodes 0 (40,000) and 2 (17,000-21,000). A surgical replacement of both leads was planned. The issue was not resolved at the time of this report. The patient was alive with no injury.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11685798
MDR Text Key246040094
Report Number2182207-2021-00648
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeSZ
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
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/19/2021 Patient Sequence Number: 1
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