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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 Intermittent Continuity (1121); Migration or Expulsion of Device (1395); Energy Output Problem (1431)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994)
Event Date 11/01/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead. Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead. Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 18-jun-2018, udi#: (b)(4). Product id: 977a275, serial/lot #: (b)(4), ubd: 09-jul-2018, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient reported that they were having issues with the stimulation sometimes feeling like it surges: they would be sitting in one spot and all of a sudden they would feel it jump to a higher number and it would be vibrating hard for 5-6 seconds and then it would stop. The patient was also feeling more sciatic pain; when their feet touched the ground it would almost feels like a shock. The patient discussed this issue with their doctor and the doctor said to have the manufacturer check the device. An x-ray was also done and it showed a slight lead migration with ¿one of the leads. ¿.
 
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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 Key11251897
MDR Text Key229434814
Report Number3004209178-2021-01651
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
Report Date 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2020
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 Received01/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/15/2019
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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