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

Model Number 3058

Device Problems Energy Output To Patient Tissue Incorrect (1209); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 02/20/2018

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 implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported the patient was feeling a pulsating in the vaginal area.The patient had a return of symptoms.There was no trauma or falls reported that could be related to the issue.The patient noted she had electromagnetic interference (emi) environmental exposure when they had a nerve test on the legs on (b)(6).The patient was able to use the patient programmer and verify stimulation was currently on program 1 at 0.4 and decreased to 0.0 and was still feeling pulsing.The patient changed to program 2 at 0.6 and stated she felt the pulsing in the butt area and the vaginal area.The patient decreased to 0.3 and was feeling slight pulsing in the vaginal area.The patient turned stimulation off and stated the pulsing stopped.The patient turned stimulation back on changed to program 3 at 0.4 was not feeling stimulation, she increased to 1.0.The patient stated stimulation was too strong and decreased stimulation to 0.9 and felt the pulsing in the vaginal area and decreased again to 0.0 and stated at 0.0 she was still feeling the pulsing.The patient changed to program 4 at 0.0 and stated now still they had the pulsing in the vaginal area.The patient verified stimulation was currently off.The patient planned to leave the stimulation off.The patient would call the healthcare professional (hcp) and tell him she called the manufacturer and they had gone through all 4 programs and even with stimulation off, the patient was still feeling the pulsing.The patient noted it was considered a sudden changed.The patient had pulsating in the vaginal area, suddenly on april 20th, she had an ¿annoying¿ pulsing in the vaginal area.The patient stated the pulsing making her feel like she had to urinate, but she didn¿t.After troubleshooting and turning of stimulation, the patient was having to sit on the toilet because she was having the pulsing in the vaginal area.The patient stated it felt like she was getting stimulation on the urethra and felt like she had to urinate.The patient verified stimulation was off.The patient noted they had a return of urgency symptoms and at times was not able to get to the bathroom in time and she was having accidents for the last couple of months.There were no further complications that have been reported 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 was received.Patient reported that all is back to normal.No further complication was noted or 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: 7454368
• MDR Text Key: 106734900
• Report Number: 3004209178-2018-08665
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• 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
• Date Manufacturer Received: 05/10/2018
• Date Device Manufactured: 09/27/2016
• 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 Age: 57 YR
• Patient Weight: 62