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

Model Number 3058

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Incontinence (1928); Muscle Spasm(s) (1966); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Distress (2329); Discomfort (2330); Electric Shock (2554)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Follow up information received from the healthcare professional (hcp) reported that the cause of the patient¿s issues were unknown.The patient was to start a week 2 bowel diary and the hcp planned to re-evaluate the patient in 2 weeks.No changes in programming were made.It was unknown if the shocking, stimulation being too high and the current ins not as effective as the previous one was resolved.Per lfc progress notes, it was reported that the patient was seen in the office on (b)(6) 2018 and electronic analysis was performed where it was confirmed there was normal impedances.It was also reported that they patient still had accidents with the new ins and that it was turned off for several days due to a surgery (noted as a ¿lap chole¿).No changes were required.It was mentioned that the settings were unable to be adjusted because the patient did not bring the correct programmer to the appointment.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

It was reported that the patient was not able to connect the programmer to the ins and that the screen goes dark.As the event indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Additional information was required to determine the cause of the event.The patient was contacted to investigate the circumstances/cause, actions/interventions taken, and resolution.No response has been received back at this time.As the device was still in use at the time this investigation was completed, no analysis could be performed.There was no indication that the event was related to a possible manufacturing issue, so a device history record review was not performed.The suspected cause of the event is that the family member was trying to use the programmer as though it were a wireless connection.However, the cause of not being able to connect and the screen going dark was not reported to the manufacturer and was unable to be obtained through investigation activities.Thus, the cause of the event could not be confirmed.The investigation determined that there was insufficient information to determine the cause of the event.Should additional information become available at a later date, the investigation will be re-opened and updated accordingly.Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.It was reported that the patient¿s ins was not working as they still had bowel incontinence (was implanted for bowel incontinence) and never experienced therapeutic benefit.They noted that their previous ins helped with their bowel incontinence, even at a low setting (0.07-0.08).The patient mentioned that their previous ins was on their right side and that the current one was on their left side and wondered if this might be the reason it was not helping them.They stated that the device gave them hope.As an action taken prior to report, the patient had tried adjusting the stimulation.In addition, the patient reported that they felt the stimulation ¿too much¿ when they increased it.Specifically, they had shocking and uncomfortable stimulation.The patient stated that on tuesday after (b)(6) ((b)(6) 2018)), they were cleaning at the hospital where they work and could feel it ¿vibrating it so much at 0.08, so she went to lower stim down to 0.07 and felt it actually shocked her vagina¿.It was further described as being a ¿very bad one as if you put your finger in the socket¿ and it was ¿just one time that it happened when she felt a bad shock¿.The patient first stated the even at 0.06, they felt the stimulation too much but later noted that it was not at 0.06 volts but felt it when they go to 0.07 (¿feel stim bad¿).This issue had occurred since (b)(6) 2018.They called their healthcare professional regarding the issue.It was also mentioned that when the device was implanted, the manufacturer¿s representative turned the stimulation up and said ¿`let me know when you feel it in your vagina'.This seemed to throw the patient off as far as why they need to feel it in the vaginal area because this is what they got the device for.With the previous device, they did not feel it in the vagina.They stated that it made sense because even getting into a truck (or something) ¿it will hit and she goes ouch¿ (¿there are certain things that hurt¿).Also, the patient reported that their right hand was jerking (¿it is weird¿).This started around the same time as the bad shock they got.The patient was upset that the device had not helped at all, that they had shocking, and right hand was jerking which they never had before.The patient was redirected for the issues.There were no further complications reported or anticipated.

• 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: 7866194
• MDR Text Key: 121770758
• Report Number: 3004209178-2018-20389
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2018
• Date Device Manufactured: 03/20/2018
• 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: 59 YR