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

Model Number 3058

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Unintended Collision (1429); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Incontinence (1928); Therapeutic Effects, Unexpected (2099)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A patient reported she had not gotten any symptom relief from her device and she had an accident on (b)(6).The patient also mentioned that she drank a lot of water so she went to the bathroom a lot.The patient stated she felt stimulation every once and a while, but was not was feeling stimulation at the time of the call.The patient was on program 1 at 1.3 v.The patient mentioned that she was sedated when she received instructions on her device.The patient increased stimulation during the call to 1.5 v and said she could feel it strongly, but that it was not uncomfortable so she left it there.The patient noted she had a follow up appoint with her healthcare professional (hcp) on the week of (b)(6).Additional information was received.The patient reported their previous device was replaced after they fell.There were no further complications that have been reported as a result of this event.The patient is implanted for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.

• 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: 9134162
• MDR Text Key: 162316065
• Report Number: 3004209178-2019-18622
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/30/2019

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: 07/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 09/30/2019
• Date Device Manufactured: 02/13/2017
• 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: 62 YR