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

Model Number 3058

Device Problems Inadequate Instructions for Healthcare Professional (1319); Energy Output Problem (1431); Inadequate Instructions for Non-Healthcare Professional (2956); Material Integrity Problem (2978)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 06/01/2018

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 with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.It was reported that the patient had 2 ins's, one for bladder and one for fecal incontinence.The patient was calling about their fecal incontinence ins.Patient reported they usually had their fecal ins on program 2 at 1.2v.It had been working really good, they could go and not wear a diaper and could have a social life.All of a sudden, their symptoms started coming back; fecal incontinence, wearing diapers again, they did not feel that they went to the restroom, they could smell it and then had to go back and change diapers and clean themselves up.They had not really changed their diet and took a probiotic.They were having accidents every day.The patient had been trying to contact their healthcare provider, but had not been able to get through.Patient also had tried changing to program 3, 1.2v, they noticed in program 3 the pulse (stimulation) was going faster.Program 3 did not help the symptoms.Patient had switched back to program 2 the morning of report.Patient reported their husband usually worked with the patient programmer.Patient thought there was a lightning bolt there, but was going to ask their husband to make sure.Patient wanted to know if they needed to go up or down or change programs.Information was reviewed and the patient was going to keep trying to reach out to their healthcare provider.The patient further reported the patient programmer manual was not consumer friendly in their opinion.They reported they were in the medical field and could not understand some of the verbiage in the manual.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider.It was reported that the sudden return of symptoms was caused by abdominal pain.The healthcare provider recommended stool bulking with insoluble fiber to resolve the issue.

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: 7669556
• MDR Text Key: 113645273
• Report Number: 3004209178-2018-15231
• 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,health professional
• 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: 02/28/2019
• 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: 07/05/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 07/18/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/20/2018; 10/04/2018; 10/04/2018
• Date Device Manufactured: 09/12/2017
• 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: 69 YR
• Patient Weight: 101