MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DRG LEAD

Model Number MN10450-90A

Device Problem Material Fragmentation (1261)

Patient Problems Scar Tissue (2060); Foreign Body In Patient (2687)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

It was reported to abbott, a patient was having problems with their hardware and enough other structural problems that they were no longer getting relief.Surgical intervention was taken where the whole drg system was explanted.Due to scar tissue, the leads broke while trying to remove them from the ipg pocket.A segment of each lead was left in the body.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

Event Description

Related manufacturer reference number:1627487-2024-00461 it was reported that during a system explant on (b)(6) 2024 ( reported in manufacturer report: 1627487-2024-00499,1627487-2024-00498), the physician was unable to explant the leads completely due to the leads being scarred and fragmented when trying to remove them from the ipg pocket.The fragmented portions of the leads were left implanted, and the procedure was completed.Surgical intervention may take place to remove the remaining lead fragments at a later date if needed.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 90CM
• Type of Device: DRG 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18608372
• MDR Text Key: 334112140
• Report Number: 1627487-2024-00462
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027160
• UDI-Public: 05415067027160
• 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
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: MN10450-90A
• Device Lot Number: 7711399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 77 KG