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

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Electromagnetic Compatibility Problem (2927); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that they couldn¿t get a clear impedance reading during implant.To troubleshoot, the healthcare provider tried removing the overhead lights and drying off the leads.They also tested the impedance with and without the tyrx pouch, and it cleared without the tyrx.It was noted that the healthcare provider decided to keep going without the pouch, and the issue was noted to be resolved.There were no patient complications reported as a result of this event.

Event Description

Additional information was received from a manufacturer representative.It was clarified that the impedance reading was invalid and the cause was determined.Additional information was received from a manufacturer representative on 2018-dec-06.It was reported that in this situation, the manufacturer representative believed the tyrx was the cause of the invalid impedance, since they were able to get a clear impedance without it.It was also noted that the impedance came up as question marks, which the rep later learned is also considered clear.No further patient complications are anticipated or expected as a result of this event.

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
• MDR Report Key: 8083176
• MDR Text Key: 127957887
• Report Number: 3004209178-2018-25676
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 11/20/2018
• Supplement Dates FDA Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR