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

Model Number 3058

Device Problems Use of Incorrect Control/Treatment Settings (1126); Electromagnetic Interference (1194); Insufficient Information (3190)

Patient Problems Incontinence (1928); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient didn't think it was working right.The patient shut it off the saturday before the report so she could have an x-ray for her oral surgery and it was turned back on, on saturday.The patient was still having trouble when she gets up in the morning and can't make it to the bathroom.The patient wanted to check if it was on.The patient tried turning it on and didn't understand the book.Previously, she increased the stimulation the saturday before the report on program 4 to 1.7 volts.During troubleshooting, it was noted that the stimulation was on, the patient was on program 4 at 1.7 volts.There were no further complications or anticipations reported with this event.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the patient re-read the book and now understands how to increase the amplitude.The patient will be given a quick reference sheet at the next appointment.Also, it was determined that the device was working correctly and adjustments to the program are being made for optimum results.There were no further complications or anticipations reported with this event.

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: 7727389
• MDR Text Key: 115569020
• Report Number: 3004209178-2018-16849
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 08/28/2019
• 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: 07/02/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 08/08/2018
• Supplement Dates FDA Received: 08/08/2018; 10/04/2018
• Date Device Manufactured: 03/09/2018
• 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 Age: 71 YR
• Patient Weight: 98