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

Model Number MN10450-50A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

Ate of event is estimated.The allegation is against 1 of 4 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: 50cm implant lead kit, slim tip, model: mn10450-50a, udi: (b)(4)serial: (b)(6), batch: 7380732.Common device name: 50cm implant lead kit, slim tip, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 7380732 common device name: 50cm implant lead kit, slim tip, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 7380732.

Event Description

It was reported that the patient experienced inadequate pain relief with their drg system.As a result, surgical intervention was undertaken on (b)(6)023 wherein the drg system was explanted to address the issue.It was also reported, that during the same surgical procedure on (b)(6)2023 [related manufacturer report number: 1627487-2023-05714], one drg lead fractured, and the physician was not able to retrieve it from the body.Therefore, there is still a partial lead with three contacts left implanted.It is unknown which drg lead did not provide adequate pain relief and which drg lead fractured whose fragment was left implanted.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• 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: 18251057
• MDR Text Key: 330222607
• Report Number: 1627487-2023-05715
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• 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: 12/13/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2022
• Device Model Number: MN10450-50A
• Device Lot Number: 7380732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• 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; DRG LEAD (3)
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 73 KG