MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL ITREL 3; INTESTINAL STIMULATOR

Model Number 7425

Device Problems Break (1069); Intermittent Continuity (1121); Low Battery (2584)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 435135, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: lead.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

Information received from a healthcare professional (hcp) via a manufacturer representative reported broken leads, which occurred during normal use.There was no issue with the implantable neurostimulator other than it had reached end of life and the hcp was happy with near 11 years of service.The consumer reported that for six (6) months the stimulation/therapy seemed inconsistent.On interrogation of the ins, it was discovered that the ins was nearing end of life and the consumer was booked for replacement, but problems with heath fund delayed the procedure by approximately six (6) months.Just prior to the procedure the ins was no longer working due to depletion.Impedance, etc.Was unable to be obtained.When the ins replacement procedure was undertaken, a broken lead was discovered.It was noted that the lead appeared to be broken at the proximal/ins end just beyond the thicker plastic that enters the ins.The consumer had to be rebooked for bilateral lead replacement.A combination of depleting ins and broken lead may have contributed to complications with providing consistent therapy.No factors noted to have led to the event.It was unclear which of the consumer¿s two implanted leads was broken.It was noted that the issue was resolved.The consumer¿s medical history included gastroparesis, chronic pain/query ehlers danios syndrome.There were no further complications reported and/or anticipated.

Manufacturer Narrative

Analysis of the lead, model 435135, serial/lot # (b)(4), found lead body all conductor broken within 10 cm of connector area.No electrical shorts were identified between circuits.Analysis of the lead, model 435135, serial/lot # (b)(4), found no significant anomaly, lead body cut through, product segmented.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ITREL 3
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6734042
• MDR Text Key: 80747521
• Report Number: 9614453-2017-02612
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

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: 03/14/2008
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 08/09/2017
• Supplement Dates FDA Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2006
• 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): Required Intervention
• Patient Age: 58 YR