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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Unexpected Therapeutic Results (1631); Inadequate or Insufficient Training (1643); Malposition of Device (2616)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Scar Tissue (2060); Swelling (2091); Urinary Tract Infection (2120); Vertigo (2134); Tingling (2171); Therapeutic Response, Decreased (2271); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information from the consumer reported that they experienced a loss or change of therapy.There was a report that the patient was not feeling stimulation and the therapy was on.It was reported that they felt like the trial was more effective.During the trial, there was at least one night they only got up twice at night but now they get up 4-5 times.It was reported that they kept a diary during the trial but the doctor told them that they didn't need to keep one after implant.They were still new to this but felt as though it wasn't doing what it was supposed to.They were not given any instructions on when to change programs and were not told what the programs were.It was explained that they were still having problems getting up, running to the bathroom, and holding themselves.The bathroom in their home was on the top floor so they had a urinal bottle because they knew there was no way they were going to m ake it.The patient wanted to know if they could increase their stimulation and stated that their healthcare professional (hcp) told them that "they don't really like to go that high." they were afraid to do this because they didn't know what was safe but knew that they were in control.Last time, they saw their hcp, on (b)(6) they increased their stimulation to 3 something and now they were at 4 or 4.6 to 4.8 and wasn't able to feel stimulation.There was a report that the patient was going to try stimulation at 4.8 volts and if their symptom didn't improve, they would contact their physician.Their main concern was if the wires could move.The patient reported that they didn't know if the wire moved.There was a report that the patient sometimes feels a little tingling then it would quit.They could feel a twinge back there every once and awhile but it was confirmed that the twinge was not uncomfortable or painful to the patient.Stimulation sensation expectations were reviewed.The patient stated that the ins was in a bad spot and that it would be easier if it was on their stomach or leg.The patient was redirected to their healthcare provider regarding increasing their stimulation and symptoms.A couple days after the implant, the patient had urinary symptoms.There was a report that the patient was doing a smoke study and they would need to spend the night there.If their symptoms didn't improve, they would need to take their urinal there.There was a report of some balance problems, where they stand up and gets vertigo and can't walk.They were still having leakage and the implant site was still a little sore plus there was kind of a bump.It was mentioned that they had a cyst removed many years ago so there was scar tissue there.The cyst was removed in the late 1950's.There was a report that things were not explained clearly.Relevant medical history includes urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes related to this event may have been updated.Medtronic, inc.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient who said things are not set up right.They further elaborated and said they have to go right away whenever they wake up or stand up.Patient still gets up about 3-4 times at night and they don't have control of their urge incontinence.At the hospital (hospital is not related), the patient was tested which indicated they had a bad urinary tract infection (uti).They further noted being prescribed water pills for the swelling in the ankles; they noted that they drink a lot of water.Prior to the call today, the patient has had reprogramming sessions with manufacture representatives (rep).During the call, the patient synched to their ins which showed stimulation was on; they mentioned feeling stimulation prior to checking.As a result of what was reported, the patient was instructed to keep track of symptom, results, and make adjustments if they don't notice improvement.Patient was directed to try and track results of each program and schedule a reprogramming session if they still don't notice any improvement.Patient further said it is difficult for them to find the ins based on where it is implanted.They did mention having greater than 50% improvement in symptom control during the trial.No further patient complications have been reported as a result of this event.

• 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: 6428494
• MDR Text Key: 70767524
• Report Number: 3004209178-2017-06240
• 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,Followup,Followup
• Report Date: 09/13/2018

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: 03/14/2018
• 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: 03/21/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: Not provided; 03/21/2017; 09/05/2018
• Supplement Dates FDA Received: 03/24/2017; 10/02/2017; 09/13/2018
• Date Device Manufactured: 09/17/2016
• 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 Outcome(s): Other
• Patient Age: 75 YR