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

Model Number MN10450-50A

Device Problems High impedance (1291); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

Date of event estimated.The allegation is against [2] of [4] [lead]; however, it is unknown which [lead(s)], therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: lead, model: mn10450-50a, udi: 0(b)(4), serial: (b)(6), batch: 6618334." common device name: lead, model: mn10450-50a, udi: (b)(4), serial: n/a, batch: ab2421.

Event Description

Related manufacturer reference number: 1627487-2024-07843.It was reported that the patient's system diagnostics recorded high impedances, upon further investigation, the lead had migrated, which was confirmed via imaging.As a result, the patient was experiencing ineffective therapy.Surgical intervention may take place at a future date to address the issue.Investigation was unable to determine which of the leads attributed to the event.

• 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: 19008659
• MDR Text Key: 338980116
• Report Number: 1627487-2024-07820
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: MN10450-50A
• Device Lot Number: 6607529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• 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 LEADS (X2)
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 75 KG