MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problem Malposition of Device (2616)

Patient Problems Inflammation (1932); Irritation (1941); Discomfort (2330); Complaint, Ill-Defined (2331); Injury (2348); Malaise (2359)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Date of event was reported as "sometime within/by the end of 2014".If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.It was reported that the patient was injured in the area of the implant (implant site), and it became "big, inflamed, and [was] still not feeling good." it was noted the patient's clothes around it would cause pressure, and she would like it removed.It was noted that the event occurred (b)(6) 2015.Additional information received from the patient on nov.14, 2018 reported that the implantable neurostimulator (ins) felt tender and irritating when touched by clothes.It was noted that it was implanted close to the skin.About a year after implant (¿sometime within/by the end of 2014¿), the current physician performed a revision when the ins was placed deeper.There were no further complications reported or anticipated.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 8077709
• MDR Text Key: 127368446
• Report Number: 3004209178-2018-25582
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2018

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: 07/28/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 11/16/2018
• Date Device Manufactured: 01/31/2014
• 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: 64 YR