MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hematoma (1884); Necrosis (1971); Complaint, Ill-Defined (2331); Test Result (2695)

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 3889, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 3889.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the manufacturer representative (rep) reported that the patient had a complications or an unknown adverse event.There was a report that the patient received a pelvic hematoma and became unwell with low hemoglobin during a tined lead trial.As a result, their bowel became necrotic and they required surgery to perform a stoma.It was reported that the issue occurred on day 8 of the test.It was reported that the implanter thought it was device related.Factors that may have led or contributed to the issue remain unknown.Intervention include a colostomy/stoma that had to be performed.The issue was not resolved.No further complications were reported.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7895469
• MDR Text Key: 120965862
• Report Number: 3007566237-2018-02823
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/20/2018
• 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