MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG SLIM TIP LEAD

Model Number MN10450-50A

Device Problem Break (1069)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/12/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2023-00005.It was reported that one drg lead had sheared at the initial needle insertion site and the other drg lead had pulled out of the epidural space.Surgical intervention was undertaken wherein the system was explanted and replaced.Therapy was restored.

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Manufacturer Narrative

The reported impedance issue was confirmed.Analysis of the returned lead a found a kink on the outer tubing where all internal wires were broken.The fractures are consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16119477
• MDR Text Key: 306879070
• Report Number: 1627487-2023-00004
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025531
• UDI-Public: 05415067025531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2019
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: AB2361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2017
• 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
• Treatment: DRG IPG (1)
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 125 KG