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  

Event Description

Explant on 11jan2024 rep, brett williams, emailed nmd complaints to report that explant was completed on (b)(6) 2024.The patient was having problems with her hardware and enough other structural problems that she was no longer getting relief.Whole drg system explant for painful hardware.The leads were both scarred in enough that they broke when trying to remove from the battery pocket.Dr.Goentzel chose to leave a piece of each lead in the body unless further problems arise.No product returned, hospital protocol was to discard the leads and battery.170 lbs ps date: 11jan2024 ppg complaint history review 12jan2024 z.Rebel: complaint history search for the last 4 years found prior report(s) on this patient: ts-1637114, ts-1637130 area: zmidwest.

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.

• 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: 18608360
• MDR Text Key: 334112069
• Report Number: 1627487-2024-00461
• 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