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

Model Number 3058

Device Problems Unintended Collision (1429); Unable to Obtain Readings (1516); Device Contamination with Chemical or Other Material (2944)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Information was received from the manufacturer¿s representative regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported the patient had multiple falls off their horse so both the patient and the physician decided to do a lead revision to help with their symptoms.No known diagnostic testing was performed.However, impedance testing prior to the surgical case showed no open or short circuits.During the case, the physician removed the ins and wrapped it in sterile water-soaked ¿raytec¿ for later use after the lead revision had occurred.When the physician went to connect the lead to the ins they noticed blood/fluid in the hub of the generator.The physician connected the lead and intra-operative impedances showed 2 of the electrode combinations displayed ¿?¿.The physician took the lead out, cleaned it, and retested impedances with the same result.The physician decided to use a new ins.Though the surgical case was for lead replacement/revision only the ins ended up being replaced due to the blood in the hub of the ins.The issue was reported as resolved at the time of report.The patient status was noted as ¿alive ¿ no injury¿.There were no further complications reported or anticipated.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) model 3058, (b)(4) showed no significant anomalies.Foreign material was observed in the ins connector port.As a result, an impedance test was performed (with a known good lead) in 0.9% saline solution and good impedances were observed using a clinician programmer.The device passed functional testing and lab functional testing determined there was good stable output on all electrical pairs as received.It was also determined the telemetry was acceptable.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: 6658485
• MDR Text Key: 78125167
• Report Number: 3004209178-2017-13473
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2017

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: 10/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 07/21/2017; 07/21/2017
• Supplement Dates FDA Received: 07/26/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 54 YR