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

Model Number 3058

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Vibration (1674); Insufficient Information (3190)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Frequency (2275); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.The patient reported that she was having difficulty with the device since implant.The patient stated that the device was loose inside of her, and it didn't work all the time.The patient reported that sometimes it vibrates really hard and other times it doesn't work at all.Patient services explained that you don't have to feel the stimulation for it to work.The caller reported that she is just having symptoms and that she has the device for the bladder.The patient stated that she was having leaking, urgency, and frequency.The patient stated that she has had relief but not really, and is looking to get more benefit.The patient confirmed that stim was on, program 1 at 2.1 volts.It was noted that the patient felt stimulation in the correct area (bike seat area).The patient tried increasing stim on program 1 up to 3.6 and stated that it was painful.Patient services assisted her in decreasing it to where it was comfortable and she brought it back to 2.1 volts.The patient stated that it was not comfortable if goes above 2.1.The patient switched to program 2 and increased to 2.7 volts.Patient services reviewed that it takes time for the body to respond to therapy, therefore titrations should be discussed with her healthcare provider (hcp).The patient was redirected to their hcp if the problem did not resolve.No further complications were anticipated/reported.

Manufacturer Narrative

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

• 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: 7728486
• MDR Text Key: 116260857
• Report Number: 3004209178-2018-16870
• 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: 10/04/2018

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: 08/28/2019
• 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: 07/20/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 03/09/2018
• 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: 35 YR