MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_INS_STIMULATOR

Device Problem Component Missing (2306)

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

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial#: (b)(4), product type: lead.Product id: 977a275, serial#: (b)(4), product type: lead.Product id: 977a275, serial#: (b)(4), product type: lead.Product id: 977a275, serial#: (b)(4), product type: lead.Product id: 977a275, serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 11-sep-2023, udi#: (b)(4) ; product id: 977a275, serial/lot #: (b)(4), ubd: 16-oct-2023, udi#: (b)(4) ; product id: 977a275, serial/lot #: (b)(4), ubd: 27-sep-2023, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 27-sep-2023, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 16-oct-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the healthcare professional (hcp) via manufacturer representative (rep) reported a lead kit issue.It was reported that during the same surgical procedure, 5 kits were found with missing contents that included stylets with the white cap, anchor removal tool, and the anchor.Factors that may have led or contributed to the issue were unknown.No actions were taken to resolve the issue.The issue was resolved.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 9560031
• MDR Text Key: 174899520
• Report Number: 3007566237-2020-00030
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• 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