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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 97715
Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 12/01/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 23-aug-2025, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 23-aug-2025, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient bent over and felt a tug in their back. A lead check was performed and showed leads dropped approximately one vertebral level. It was noted the impedance check was normal. The patient was still receiving adequate pain relief. No further intervention was planned. The issue was resolved at the time of report.
 
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 23-aug-2025, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 23-aug-2025, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient bent over and felt a tug in their back. A lead check was performed and showed leads dropped approximately one vertebral level. It was noted the impedance check was normal. The patient was still receiving adequate pain relief. No further intervention was planned. The issue was resolved at the time of report.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13024910
MDR Text Key285241419
Report Number2182207-2021-02195
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00763000315467
UDI-Public00763000315467
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2022
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/21/2021
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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