MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3023

Device Problems Inadequate Instructions for Healthcare Professional (1319); Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 02/01/2008

Event Type  Injury  

Manufacturer Narrative

The main component of the system and the other applicable components are: product id: 3093-28, lot# v008504, implanted: (b)(6) 2006, explanted: (b)(6) 2008, product type: lead.Product id: 3095-10, serial# (b)(4), implanted:(b)(6) 2006, explanted: (b)(6) 2008, product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator.It was reported that, on (b)(6) 2008, pre-operative orders were signed due to a wound infection and the device was removed on (b)(6) 2008.On, or about, (b)(6) 2017, it was found that the patient had pain and a ct scan was performed.The scan showed multiple, metallic density objects, as well as possible catheter/tubing fragment in the right, lower back in the area where the device was.On, or about, (b)(6) 2017, a 1.5 inch plastic piece of fragment was removed by a healthcare professional (hcp) from the site where the device had been removed.It was claimed that the hcp was not properly instructed on the insertion of the device and, as a result, the patient was forced to undergo surgery to fix the improper placement of the device.They also stated that the hcp was not provided proper instruction on extraction of the device and, as a result, the patient was left with fragments of their device for nine years until they were extracted by another hcp.The patient had pain and suffering during the nine years they had the fragments in their body, which affected their love, companionship, and conjugal affection with their spouse.It was also noted that the patient had repeated discomfort and occasional swelling over their right, lower back, where the device was implanted, even after it was removed.They stated that the standard of care expected in pre-operative evaluation and preparation of surgical patients, operative procedures, and post-operative procedures were deviated from, causing the patient to be placed at an increased risk of retention of fragments of the device.There were no further complications reported or anticipated.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7231765
• MDR Text Key: 98695534
• Report Number: 3004209178-2018-01763
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2018

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: 11/28/2007
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 01/31/2018
• Date Device Manufactured: 06/06/2006
• 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