MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7425

Device Problems Break (1069); Failure to Deliver Energy (1211); Battery Problem (2885); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 06/17/1996

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3986ilc, lot #: n22522, implanted: (b)(6) 1996, product type: lead.Other relevant device(s) are: product id: 3986ilc, serial/lot #: (b)(4), ubd: 15-apr-2000, udi #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient implanted for peripheral causalgia, rsd/causalgia-complex regional pain syndrome and peripheral causalgia.The patient reported that their first implantable neurostimulator (ins) only lasted 9-10 months, so the healthcare provider (hcp) needed to replace it.The patient stated that the device never helped their leg pain and they never felt stimulation.They noted that during the replacement surgery on (b)(6) 1998, the hcp found there was spinal fluid in the lead and that the lead was broken.The patient stated that the hcp left the device in their body; non-functional.They added that they were not positive how long the device lasted because they were constantly shutting it on and off.No further complications were reported or anticipated.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient on 2019-aug-26.The patient indicated that they don¿t know what their exact weight was but an estimate is about 135-140 pounds.No further complications were reported/are anticipated.

• Brand Name: ITREL 3
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8795845
• MDR Text Key: 151222206
• Report Number: 3007566237-2019-01575
• 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
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 61