MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure to Deliver Energy (1211); Energy Output Problem (1431); Vibration (1674); Communication or Transmission Problem (2896)

Patient Problems Incontinence (1928); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Event date is approximate.Occupation: non-healthcare professional.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 was no longer feeling vibration from the therapy and had a return of symptoms.Patient was calling for assistance in arranging for a manufacturer representative to be at their healthcare provider appointment to check the ins battery.Patient had already called and left a message for their healthcare provider.Patient reported this as a sudden return of symptoms.The patient was reporting poor communication and seeing a screen with a question mark.The patient reported they had replaced the batteries and did everything the book suggested.The patient was redirected to their healthcare provider due to the date of implant of their ins.Patient reported they had only had the device checked once in the office by a manufacturer representative and they last connected with their ins about 6 months prior to increase the setting.When they increased it was uncomfortable, but they thought it would subside, but it didn't so they turnedthe stimulation down after a couple of days and it felt better.The patient reported the stimulation was too strong in their labia.They also reported increased incontinence.The patient reported they had an appointment scheduled with their healthcare provider on (b)(4) 2018.No further complications were 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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7742204
• MDR Text Key: 116723437
• Report Number: 3004209178-2018-17227
• Device Sequence Number: 0
• Product Code: EZW
• 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
• 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: 08/28/2013
• 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: 08/01/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 03/07/2012
• 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: 65 YR