MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37704

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Therapeutic Response, Decreased (2271); Loss of consciousness (2418)

Event Date 02/17/2014

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: neu_label_acc, product type: accessory.

Event Description

A consumer reported that the patient needed an mri due to headaches.It was noted that the headaches started in 2014 and subsided a little bit but came back "with a vengeance" over the past 2-3 months.The patient blacked out for a few seconds when they get the headaches.The patient couldn't understand the patient programmer manual and couldn't figure out what they were doing wrong and wanted to watch a video.The implantable neurostimulator (ins) was indicated for non-malignant pain.

Manufacturer Narrative

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

• Brand Name: ITREL 4
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5718216
• MDR Text Key: 47189505
• Report Number: 3004209178-2016-11962
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 37704
• Device Catalogue Number: 37704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR