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

Model Number 3058

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.The patient reported that she went to her healthcare provider (hcp) who noticed "part of it had moved" referencing the implant.The patient stated that the hcp told her that the ¿manufacturer would want to have it removed¿ via-surgery, but she reported she had no problems with therapy stating, the therapy was working just as well as when it was implanted, so the hcp decided she wouldn't do anything.The patient stated she had no falls, but a few years back she bent down to the floor which was possibly why it moved, but "nothing she could see that would be a part" of why it moved.The patient also reported using a handheld massager on husband's back reporting "for me it felt like a jack hammer", and patient stated she felt it all the way down into her labia from 8pm "all evening".The patient asked if using handheld massager on her husband would affect the ins.It was further noted that the patient therapy was at 2.7.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from the patient indicated there was no steps taken since patient currently don¿t feel any discomfort and there was no change in its effectiveness.The doctor feels no need to do anything.There was no change in their therapy and patient no longer uses that hand held device.

Manufacturer Narrative

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: 7736820
• MDR Text Key: 116259813
• Report Number: 3004209178-2018-17089
• 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
• 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: 03/14/2017
• 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: 07/30/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/16/2018; 08/08/2018
• Supplement Dates FDA Received: 08/24/2018; 10/04/2018
• Date Device Manufactured: 09/16/2015
• 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 Weight: 57