MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 3023

Device Problem Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2021

Event Type  Injury  

Event Description

The manufacture representative reported that the patient¿s full system was revised and hoping for a better result with new lead placement in line with optimized lead insertion technique along with full body mri eligibility.Patient said it felt much different than 10 years ago.The patient was booked for ins replacement after she had decided to let the battery run flat and not do anything about it for a couple of years (unknown time it has been inactive) as she didn¿t think it did much.She decided to try again so was booked for the ins replacement as ins was eol and unable to be interrogated along with the existing lead and extension.After opening the ins pocket the 7489-10 extension was disconnected from the 3093-28 lead by removing the boot and undoing the 4 grommet screws where it was noted that the insulation between the lead and the first electrode (electrode 0) of the proximal head end was no longer intact and had separated from the electrode.The decision was made for the lead to then be explanted as well and the full system replaced with the new full body mri conditional system to the patient¿s happiness post operatively.

Manufacturer Narrative

Concomitant medical products: product id: 7489-10, serial#: unknown, explanted: (b)(6) 2021, product type: extension.Product id: 3093-28, serial#: unknown, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 3093-28, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12853160
• MDR Text Key: 281090004
• Report Number: 9614453-2021-04379
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2012
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2021
• Date Device Manufactured: 12/22/2010
• 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: 65 YR
• Patient Sex: Female