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); Insufficient Information (3190)

Patient Problems Pain (1994); Skin Irritation (2076); Therapeutic Effects, Unexpected (2099); Urinary Tract Infection (2120)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: a520, serial#: unknown, product type: software; product id: 3889-28, lot#: va1ynf3, implanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot#: (b)(4), ubd: 07-mar-2023, udi#: (b)(4).Date is approximate with month/year validity.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The patient reported that they were not sure if the lead or the device was acting up.The patient reported that the device was not helping with their symptoms.The patient reported they were not feeling stimulation and they were having pain where the lead was.The patient stating that they kept getting infections and their primary care health care physician (hcp) thought that the issue was the lead.The patient reported that the bladder infection moved to their lead and noted that their urine output had not changed.The patient reported that it was very sensitive where the lead was and stated that they didn¿t know if the lead moved or if the infection caused something.The patient reported that the handset shut off when they tried to change programs.While on the call, patient services had the patient turn the handset off and then back on and the patient was able to change programs.The patient was redirected to follow up with their hcp to have the device checked.There were no further complications reported.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10246427
• MDR Text Key: 199272787
• Report Number: 3004209178-2020-11803
• 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: 07/08/2020

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: 09/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/08/2020
• Date Device Manufactured: 03/19/2019
• 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: 24 YR