MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7425

Device Problems Unable to Obtain Readings (1516); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Displays Incorrect Message (2591); Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id 3487a-33, lot# j0333717v, implanted: (b)(6) 2003, product type: lead.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with a neurostimulator for other chronic/intract pain (trunk/limbs).It was reported that the battery check uncovered a low battery alert.The therapy appeared to be good and the patient had cervical stimulation at approximately 0.5v.It was also reported that the patient lost their controller years ago and had not used their neurostimulator.It was reported that this was not due to a complaint.The patient was using their garbage disposal switch to "shock" themselves which made the cervical pain better.This was reported to be the patient's alternative to the neurostimulator.The patient had just gotten a new managing health care professional (hcp).Impedance measurements were taken.The therapy measurement was 238 ohms: c0=???, c1=395, c2=1537, c3=290, 01=???, 02=1537, 03=???, 12=1537, 13=369, and 23=1537.During the call it was reviewed that a possible lead revision as well as an implant replacement could be potentially needed.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 3487a-33, lot# j0333717v, implanted: (b)(6) 2003, product type: lead.

Event Description

Additional information received reported that the patient would be scheduled for a revision.Actions taken to resolve the impedance measurements was that the battery was turned off and would be scheduled for a revision.

Manufacturer Narrative

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

Manufacturer Narrative

H1: please note that a serious injury has not occurred at this time.This file is being reported for a malfunction.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.

Event Description

Additional information was received from the patient on 2019-jul-02.The patient indicated that their pain stimulator no longer works so they were cold transferred to patient services.The patient indicated that the implant doesn¿t work anymore.When they bend, they feel shocking in their arm.Otherwise, it feels dead.The patient had their ins checked 3 years ago and it was confirmed to be dead.The patient also turns the water on and turns the garbage disposal on to receive relief in the meantime as that shocks their arm and wakes it up.Patient services mailed a physician listings to the patient as the patient indicated they can¿t get anyone to remove it.The event date was stated to be 5 years ago.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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 5876114
• MDR Text Key: 52105148
• Report Number: 6000032-2016-00105
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2004
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/15/2016
• Supplement Dates Manufacturer Received: Not provided; 08/15/2016; 07/02/2019
• Supplement Dates FDA Received: 09/08/2016; 09/29/2017; 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR