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

Model Number 3058

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Pain (1994); Discomfort (2330)

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

Date is approximate.Other applicable components are: product id: 3889-28, lot # va1nyyx, implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: va1nyyx, ubd: 08-feb-2022, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a friend/family member of a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The patient's mother reported that the patient was having trouble with their device the day of the report.They reported they felt a sharp pain every 3-5 minutes at the ins site and a little to the side of the ins, they were guessing that it was in the area of the wires.Patient was also feeling throbbing in the vaginal area.The patient stated it hurt one other time and they turned it off and the pain went away, when they turned it back on it was fine.Patient turned stimulation off about an hour prior to the report and it was still bothering them.It did not go away.Patient was at school and in tears.There were no falls or trauma reported that were related to the event.It was reported that this was a sudden change.The patient was redirected to follow-up with their healthcare provider.No further complications were reported or anticipated.

• 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: 7859663
• MDR Text Key: 121920300
• Report Number: 3004209178-2018-20190
• 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
• Report Date: 09/10/2018

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: 10/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/10/2018
• Date Device Manufactured: 04/16/2018
• 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 Age: 15 YR