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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 37703
Device Problems Break (1069); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, product type: lead. Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown. 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 failed back surgery syndrome and spinal pain. The reason for call was pt reported they haven't been able to use therapy because they were experiencing strong shocking sensations. Pt stated they've had falls and thinks the shocking sensation may be due to falling. Patient services (ps) attempted to clarify dates of the falls and when the shocking sensations began and pt stated they've had a stroke and don't remember. Pt explained that after they had the stroke, they didn't remember the device was implanted in them. Pt stated they've fallen quite a bit. Pt also mentioned they've had three devices replaced and confirmed all three were due to normal battery depletion. Pt does not currently have a managing hcp at this time and stated they hcp they were seeing passed away. The patient also reported they had a lead wire replaced due to falling and breaking the lead. Patient services (ps) attempted to confirm an event date and pt stated they don't remember.
 
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Brand NameITREL 4
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12249347
MDR Text Key264767639
Report Number3004209178-2021-11651
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 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2017
Device Model Number37703
Device Catalogue Number37703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/29/2021 Patient Sequence Number: 1
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