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

Model Number NEU_ENS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Staphylococcus Aureus (2058); Test Result (2695)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot #: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.Product id: 3889-28, lot #: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.Product id: 355018, lot #: (b)(4), product type: accessory.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 01-aug-2022, udi#: (b)(4).Product id: 3889-28, serial/lot #: (b)(4), ubd: 01-aug-2022, udi#: (b)(4).Product id: 355018, serial/lot #: (b)(4), ubd: 06-oct-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the health care provider via the manufacturer representative reporting that five weeks after the leads were implanted, the implantable neurostimulator (ins) was intended to be implanted.When opening the pocket where the lead was connected to the extension, it was observed that the pocket was purulent.There were no external contributing factors.The patient was examined.The action taken was the leads were explanted and the patient was treated with antibiotics.The health care provider analyzed the lead in bacteriology.The following results were found: smear test of wound performed intraoperatively revealed moderate amount of gram-positive cocci, moderate amount of leucocytes, cell detritus in aerob.Cultures.Depending on the smear test, there was suspected staphylococci or staphylococcus aureus.It was noted that other surgeries done at the same time as this event were being checked if they were affected by potential contamination.The issue was note resolved.The patient was alive with no injury.No further complications were reported.

• Brand Name: EXTERNAL NEUROSTIMULATOR
• 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: 8095715
• MDR Text Key: 128076930
• Report Number: 3007566237-2018-03390
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/21/2018
• 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 Outcome(s): Required Intervention