MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number NEU_INTERSTIM_INS

Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190)

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

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are : product id 3889-28, lot# va1plvz, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 06-mar-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor it was reported that the specified lead was placed and tested without any unusual anomalies.After tunneling the lead and connecting the extension, they tested for motor response again and noticed that electrodes 0,1, and 2 were not inducing a motor response equivalent to the response observed when lead alone was being tested.Concerned there might be a connection issue, the health care professional disconnected lead from extension and tested the lead alone.However, the same problematic pattern was observed (i.E.: electrodes 0,1, and 2 did not induce a motor response even at maximum amplitudes, and electrode 3 still induced a motor response at<(><<)>2v).The mdt rep started that x-ray revealed no migration of lead and they could not discern any visible damage to the lead itself.This lead was removed and another lead was placed without issue.No symptoms were reported and no further complications were noted or anticipated.

• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7794618
• MDR Text Key: 117578279
• Report Number: 3007566237-2018-02470
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• 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: 59 YR