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

Model Number 3058

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, lot# unknown, product type: lead.Product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding their implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that patient had their system removed so they could have an mri to diagnose the cause of their ongoing back pain.During the removal process, a portion of the lead was left in the patient and patient stated they could see all 4 contacts were present and in a line on the x-ray.Patient talked to surgeon about going after the partial lead but there was risks and concerns with the surgery given the depth and location of the lead.Patient had been denied an mri by two facilities.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient and it was reported that the lead segment was buried in time and it showed in x-ray as 4 bright dots.Patient said no steps were taken to resolve the partial lead being left in.The surgeon did not offer a resolution.Patient mentioned the lead prohibited an mri for back pain which was the sole reason for the surgery.No further complications were reported.

Manufacturer Narrative

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

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: 7565488
• MDR Text Key: 109949382
• Report Number: 3004209178-2018-12470
• 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,Followup,Followup,Followup
• Report Date: 10/05/2018

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: 05/14/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 07/02/2018; 08/06/2018; 08/08/2018
• Supplement Dates FDA Received: 07/12/2018; 08/06/2018; 10/05/2018
• Date Device Manufactured: 11/15/2015
• 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: 77 YR
• Patient Weight: 64