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

Model Number 3058

Device Problems Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problems Discomfort (2330); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 12/12/2017

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 an implantable neuro stimulator (ins) for fecal incontinence and gastrointestinal/ pelvic floor.It was reported that patient began having an intense palpitating in the bicycle seat area.Patient stated it occurred suddenly at work.Patient stated it was so intense to the point of having difficulty walking.Patient stated they lowered the setting from 1.4 to 1.3 , which helped subside the sensation , but it was still intense.The option of lowering further was reviewed.Patient lowered to 1.2 and stated they could stand/walk ok but the sensation was weird.Stimulation sensation consideration was reviewed and set it to a comfortable level.Patient mentioned the day of the report was the first day they were not feeling discomfort where the ins incision was located.Patient noted that they had to sit a certain way otherwise.Patient noted that their coccyx-area was sore following implant, since the doctor had to poke a couple times as it was hard to fit, but patient stated that went away last week.There were no trauma/falls reported that could be related to the issue.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information received from patient as the cause of sudden intense palpitating was not determined but it only speculated that their wires moved or inflammation decreased.Patient weight was 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: 7160698
• MDR Text Key: 96366883
• Report Number: 3004209178-2018-00139
• 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
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• 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
• Date Manufacturer Received: 02/20/2018
• Date Device Manufactured: 08/29/2017
• 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: 55 YR
• Patient Weight: 100