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

Model Number 3058

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Sensing Problem (2917); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event was reported as: "probably a week ago" (b)(6) 2018.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 urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient had stimulation in the wrong location.The patient stated that they had issues because the stimulation was ¿jumping around¿ in their lower area.The issue state ¿probably a week ago¿ ((b)(6) 2018).They felt stimulation their inner thighs then in the lower buttocks then the bike seat area.The stimulation would go from one place to the next.This occurred when the patient was in different positions.There were no falls or trauma reported that could be related to the issue.The manufacturer offered assistance but the patient did not have their programmer with them at the time of report.The patient stated that their healthcare professional (hcp) gave them access to all the programs and was going to contact the manufacturer back to see if there was a program where they felt the stimulation in the correct bike seat area.There were no further complications reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7678678
• MDR Text Key: 114411673
• Report Number: 3004209178-2018-15522
• 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: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

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: 06/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/05/2018
• Date Device Manufactured: 12/21/2017
• 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 Age: 48 YR