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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97725
Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431)
Patient Problems Pain (1994); Dizziness (2194); Neck Pain (2433)
Event Date 07/27/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 977d260, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021-07-28, product type screening device, product id 977d260, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: screening device, product id: 97725, serial#: (b)(4), explanted: (b)(6) 2021, product type: external neurostimulator. Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 26-may-2025, udi#: (b)(4); product id: 977d260, serial/lot #: (b)(4), ubd: 27-may-2025, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Clarification was received from a manufacturer representative which reported that the patient received a new wireless external neuro stimulator and lead after the first trial lead was pulled on (b)(6) 2021. Refer to manufacturer report # 2649622-2021-15790.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12368816
MDR Text Key268207426
Report Number3007566237-2021-00081
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/25/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/27/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/21/2021
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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