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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Break (1069); Failure to Deliver Energy (1211); Unintended Collision (1429); Energy Output Problem (1431); Patient Device Interaction Problem (4001)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead, product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 28-jul-2024, product id: 977a260, serial/lot #: (b)(4), ubd: 16-sep-2024, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fbss leg/back and spinal pain. It was reported that the patient thinks they "broke the wire" in their back. Caller stated they went over a step and their knee gave out and they twisted their back bad and now they don't feel stim on the right side. Caller states he had some x-rays taken last week but is still waiting on the results. Caller states he has turned it up and feels it strong on the left but not feel anything on the right. Caller is wondering if one group is better/stronger than another.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11109120
MDR Text Key224815884
Report Number3004209178-2021-00056
Device Sequence Number1
Product Code LGW
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/09/2020
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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