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

Model Number 3058

Device Problem Failure to Deliver Energy (1211)

Patient Problems Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099); Tingling (2171); Urinary Frequency (2275)

Event Date 08/23/2017

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

The patient was very unhappy because she was in a high scale store shopping and from the vagina to the top of her knees she was totally wet and did not even know it.Patient noted she was totally wet in the back too and was humiliated and crying.Patient reported she was not sure if this was because she was on her feet too much for a good 2 hours.Patient stated so then she went to the doctor and the physician's assistance thought the patient might have an infection so she put her on antibiotics.Patient then reported the same thing happened again, she felt wet down there and went into the bathroom and "it was coming out of her like a leaky faucet".Patient stated she went through 3 kotex pads in 45-50 minutes.Patient reported she took a shower and thought it was ok but then it came out and was dripping again.Patient reported she tried increasing stim "maybe 5 days ago" but noted that the 2nd accident happened after increasing stim.Patient noted she increased stim to 1.3v.It was noted stimulation was off.The patient was assisted in turning stim on and felt stimulation.The patient reported she may have accidentally turned stim off.Patient also asked, if stim was off, why was she feeling like a tingly sensation all the time.Before turning stim back on however patient reported she was not currently feeling stim.After walking patient though turning stim back on, patient reported she felt the tingly sensation again.Patient reported she would like to keep stim set to 1.3v.The patient indicators for use are for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.No further complications were reported/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: 6854082
• MDR Text Key: 85572862
• Report Number: 3004209178-2017-19054
• 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
• Report Date: 09/08/2017

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: 11/14/2018
• 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: 09/06/2017
• Initial Date FDA Received: 09/08/2017
• Date Device Manufactured: 05/17/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR