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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 7425
Device Problems Electromagnetic Interference (1194); No Device Output (1435); Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 07/15/2021
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that patient had neck surgery and went to turn on ins for pain but was unable to turn ins on.  patient stated they replaced the 9v battery in the pp and it seems the ins is depleted but their doctor wants to get the implant check to confirm if the ins is depleted. The patient was redirected to their healthcare provider to further address the issue. Mdt rep reports patient (pt) had unrelated neck surgery two weeks ago and after the surgery the 7425 itrel 3 was not functioning. Rep will discuss with doctor about replacing the itrel 3.

 
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Brand NameITREL 3
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
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 Key12259428
MDR Text Key264507770
Report Number3004209178-2021-11739
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
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,Followup
Report Date 08/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/14/2012
Device MODEL Number7425
Device Catalogue Number7425
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/20/2010
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: 08/02/2021 Patient Sequence Number: 1
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