MAUDE Adverse Event Report: MEDTRONIC INC. INTERSTIM II NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE

Model Number 3058

Device Problem Defective Device (2588)

Patient Problems Incontinence (1928); Pain (1994)

Event Date 11/27/2018

Event Type  Injury  

Event Description

Interstim ii device initially placed on (b)(6) 2018.In (b)(6) 2018, patient was evaluated by his surgeon and complained of poor urinary control and pain.Device malfunctioned and was removed.

• Brand Name: INTERSTIM II NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC INC. ; minneapolis MN
• MDR Report Key: 8186376
• MDR Text Key: 131306620
• Report Number: MW5082366
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Weight: 79