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

Model Number 3058

Device Problems Energy Output Problem (1431); Patient-Device Incompatibility (2682)

Patient Problems Incontinence (1928); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 10/26/2012

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 healthcare provider (hcp) via a clinical study regarding a patient with an implantable neurostimulator (ins).It was reported that the patient was experiencing worsening of urinary symptoms, including urinary frequency, urge incontinence, and nocturnal enuresis.The patient was reprogrammed on (b)(6) 2013 as their symptoms continued.The patient had frequency during the daytime, about three to four hours, and twice during the night.However, it was also reported that the patient experienced incontinence at night time.The patient was not doing well, as the urinary frequency, urinary urge incontinence, and nocturnal enuresis were bad.After the ins was adjusted on (b)(6) 2013, the patient¿s urinary symptoms improved, and the outcome was considered to be resolved.It was further reported that the patient experienced vaginal pain and pressure.This would occur when the stimulation was increased to treat symptoms.When stimulation was decreased, the vaginal pain and pressure resolved but the urinary symptoms returned.Interventions included reprogramming and medication.The amplitude was decreased, the level was increased from 3 to 3.4, and vitamin a & d ointment was administered.The patient experienced continued vaginal pain with sitting after the adjustment and had mild relief with use of the ointment.It was reported that the patient was feeling slightly better on (b)(6) 2013 but the issue was not resolved.On (b)(6) 2013 it was noted that the patient was satisfied with the adjustment.It was further reported that the patient experienced a sudden onset of increased incontinence for two days, which began on (b)(6) 2013.The patient¿s symptoms were ongoing, and medication was administered on (b)(6) 2013.It was noted that the patient had an excellent response with myrebetriq.After stopping the medication and turning the ins off, the patient experienced an increase in urinary frequency/urgency.The symptoms continued because the patient would turn the ins off and on as needed due to the vaginal pain.The etiology of the event was noted as possibly related to the device or therapy and related to programming/stimulation, as the patient turned off the device and discontinued medication.The outcome of the event was noted as unresolved at the time of study closure.No further complications were reported or anticipated.Indications for use are gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stimulation.

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.

Event Description

Additional information from the healthcare professional (hcp) on august 15th reported therapy resumed.The hcp noted on (b)(6) 2013 the interstim was adjusted turned off x1 then started on program 1 at 3.8 with the patient feeling sensation in the pelvis.It was noted the symptoms were ongoing on (b)(6) 2013, the patient had an excellent response to myretrio, 25 mg.Additional information from the hcp on august 15th reported the final programming date and time for the most recent interrogation prior to the event was (b)(6) 2013.There were no further complications that 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 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: 7748223
• MDR Text Key: 116725178
• Report Number: 3004209178-2018-17392
• Device Sequence Number: 1
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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: 02/14/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 08/15/2018; 08/08/2018
• Supplement Dates FDA Received: 09/11/2018; 10/02/2018
• Date Device Manufactured: 08/20/2012
• 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: 89 YR