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

Model Number 3058

Device Problem Premature Discharge of Battery (1057)

Patient Problems Urinary Frequency (2275); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Date of event: no information.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation a nd gastrointestinal/pelvic floor.It was reported that the patient kept track of how many times they got up last night.The first time they got up was an hour after they went to bed, then 30 minutes later they had to get up, after that time might have been 15 minutes.This issue has occurred the last two nights.The patient was redirected to their healthcare provider to further address the issue.The patient's relevant medical history included they sleep on their right side, and device is on left.Incision is rather sore.They wanted to know if they can sleep on the left side.Patient services redirected them back to their doctor.Patient has a follow up with doctor in 2-3 weeks.On (b)(6) 2021 additional information was received from the patient reporting that the first device died earlier then expected because the settings were to high.Patient kept getting up 3-4 times at night within one hour.Patient services asked them when this started and they said they didn't know.The patient said they were using up too many incontinence products.Patient had the stimulator replaced last friday.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13120248
• MDR Text Key: 283080481
• Report Number: 3004209178-2021-19171
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/30/2021

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: 01/28/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 12/30/2021
• Date Device Manufactured: 08/10/2019
• 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 Sex: Female