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

Model Number MN10350-50A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

The allegation is against 1 of 2 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: drg slim tip lead, model: mn10350-50a, udi: 05415067027139, serial: (b)(4), batch: 8754815.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

Event Description

It was reported that during procedure to pull patient's trial leads the physician had difficulty removing the right l3 lead.As such, once the lead tail came out, the lead tip with all four contacts remained in situ.X-rays showed the lead tip fragment was still intact and located by the spinous process.Surgical intervention may be undertaken to address this issue.

• Brand Name: KIT TRIAL SLIM TIP LEAD, 50CM
• Type of Device: DRG TRIAL 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: 16716441
• MDR Text Key: 313061036
• Report Number: 1627487-2023-01688
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027139
• UDI-Public: 05415067027139
• 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: 04/11/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: MN10350-50A
• Device Catalogue Number: MN10350-50A
• Device Lot Number: 8583625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• 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 TRIAL LEAD (1)
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 70 KG