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

Model Number 3058

Device Problems Vibration (1674); Insufficient Information (3190)

Patient Problems Incontinence (1928); Irritation (1941); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Alteration In Body Temperature (2682)

Event Date 10/31/2014

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 (con) regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the patient had some questions as to why she was in so much back pain with this thing.The patient reports since implant she had back pain going up the spine and she can feel stimulator vibrating and her husband can put his hand on the site and feel it vibrating.She reports the incision area of implant was warm and hot for couple days.She always had coughing spells and coughs a lot and hard for few minutes and wet herself when she coughing.The therapy did not take away wetting herself when she coughs.She was not sure why the therapy was not helping her when she coughs.The patient reports 50% relief of symptoms.The hcp (healthcare provider) did not provide instruction as to adjusting stimulation.It was confirmed that the patient did not have fall or trauma.Current setting was program 3 at 0.5 volts but she was at 0.3 volts and she increase stimulation.Adjusted stimulation to program 4 at 0.30 volts.Additional information was received from the patient on october 9th, 2019.The patient reported that the reason for her call was asking if her device was on a recall.Patient services reviewed information.The patient stated that her device did not work and she had severe incontinence problems.The patient stated that she was still having to wear sanitary napkins and diapers.The patient stated that she is incontinent when she coughs.The patient stated that she tried increasing to 4, but it was too uncomfortable.The patient stated that it did not feel like it did when she was first implanted.The patient programmer showed that stim was on.The caller changed from 3.0 on p2 to 3.25 on p3.The caller confirmed it was comfortable.Patient services reviewed what programs are.The patient stated that she may want the ins removed.Patient services sent listings for managing and implanting, and reviewed a general surgeon can remove ins.No further complications were anticipated/reported.

• 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: 9235900
• MDR Text Key: 176989255
• Report Number: 3004209178-2019-20387
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2019

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: 04/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/24/2019
• Date Device Manufactured: 10/14/2014
• 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 Age: 49 YR