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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems High Blood Pressure/ Hypertension (1908); Undesired Nerve Stimulation (1980); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Test Result (2695)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient did not feel positive that the therapy was on because they were not urinating as much as they thought they should.This started ¿probably a couple of days¿ ago.They also did not feel the stimulation (unknown when this issue started).The patient stated that they wore a depends and usually got up twice during the night to change and use the bathroom but last night, they didn¿t and had a small amount of urine (¿barely trickled¿).It was noted that the patient got the implant to treat urinary retention and, without the device, they had to catheterize a lot.In addition, the patient reported that they were prone to uti¿s so it made it difficult to know if the urinary changes were due to the therapy or the uti.They had to go to the hospital emergency room (er) where they checked their blood pressure and found it was high.It turned out they had a uti and was told their kidney function was ¿one little number off¿ but nothing serious.The patient did not remember when the uti issue occurred but mentioned it was a ¿couple of months ago¿.It was also reported that the patient¿s doctor had to lower the settings because it was sending ¿some impulses down their right leg¿ which was bothering them because they had surgery on it.It bothered them so much that when they lied down, they had to turn the stimulation off because it hurt/bothered their knee (unknown when this issue started).Using the programmer, it was determined that the patient was on program 3 at 0.6 and the stimulation was on.The patient then successfully increased the stimulation from 0.6 to 0.8 where it was confirmed they felt the stimulation sensation slightly.They were also redirected to their healthcare professional (hcp) for if the issues did not resolve.It was noted that the patient had an appointment with their managing hcp on friday ((b)(6) 2019).There were no further complications reported or anticipated.

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: 8441140
• MDR Text Key: 139478067
• Report Number: 3004209178-2019-05789
• 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,Followup
• Report Date: 03/25/2019

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: 01/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 03/25/2019
• Date Device Manufactured: 07/31/2014
• 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): Other
• Patient Age: 76 YR