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 Foreign Body In Patient (2687)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.A rn called tech support and inquired if the patient is mri conditional was reported to abbott.After an explant that left a broken lead remaining.Rn reported patient having system explanted, rn reported one broken lead remaining in the lumbar region.Reason for explant was because of a broken lead.Tech support advised patient is not mri conditional for any scans with an abandoned part.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 event could not be conclusively determined.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: 8433177.Common device name: 50cm implant lead kit, slim tip, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 8433177.Common device name: 50cm implant lead kit, slim tip, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 8433177.

Event Description

Related manufacturer reference number: 1627487-2024-07969.It was reported the patient had a broken lead.As the result, surgical intervention took place wherein the system was explanted.The broken lead remained implanted.

• 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: 19056973
• MDR Text Key: 339553094
• Report Number: 1627487-2024-07970
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: (01)05415067027153(10)8433177(17)240420
• 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: 04/07/2024

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 Expiration Date: 04/20/2024
• Device Model Number: MN10450-50A
• Device Lot Number: 8433177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2022
• 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 IPG.; DRG LEADX2.
• Patient Sex: Female