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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

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MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97725
Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977d260, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: screening device. Product id: 977d260, serial#: (b)(4), implanted: (b)(6) 2021, product type: screening device. Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 26-may-2025, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a trial patient via manufacturer representative who started a spinal cord stimulation trial on (b)(6) 2021. It was reported that the patient suspects that she removed the tape/bandages while asleep. One trial lead migrated out of the epidural space, but the other lead is still intact. The patient had a follow-up appointment on (b)(6) 2021, and it was found that all tape was removed and the leads were disconnected from the wireless external neurostimulator. The physician removed the migrated lead, redressed the bandages, and reconnected the one lead which was still in the epidural space. The issue was resolved. Surgical intervention was not planned or performed. There were no patient symptoms reported.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis,mn PR 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis,mn PR 55421 1200
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12275270
MDR Text Key264997064
Report Number2649622-2021-15685
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number97725
Device Catalogue Number97725
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/12/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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