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); Application Program Problem: Parameter Calculation Error (1449); Use of Device Problem (1670); Insufficient Information (3190); Data Problem (3196)

Patient Problems Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Dysuria (2684)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

Date is approximate with year validity.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported by the patient they did not understand why they were on 1.4v but when they first got their device they were always on 1.2v.The patient stated they did not know if this had something to do with their ¿fluid.¿ when asked for clarification, the patient stated they were not ¿going potty¿ like they should and that their bowels were ok but that it was just their ¿water.¿ the patient confirmed that they meant the device was not helping with their urinary symptoms.The patient stated they didn¿t understand how their settings changed and they asked if they may have pressed a button or something.Patient services reviewed the settings were only changed by using the programmer.While on the call the patient synced with their programmer and it showed that stimulation was on at 1.4v on p1.The patient then increased stimulation to 2.0v and confirmed they felt stimulation.The patient did not know their health care physician (hcp) information.The patient noted they were new to the device.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Patient also reported that she had problems with her device and programmer.

Manufacturer Narrative

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

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: 7672180
• MDR Text Key: 113961458
• Report Number: 3004209178-2018-15350
• 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: Other
• Type of Report: Initial,Followup,Followup,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: 11/14/2017
• 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: 07/06/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 07/06/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/11/2018; 10/04/2018; 10/05/2018
• Date Device Manufactured: 05/24/2016
• 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: 81 YR