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

Model Number MN10450-50A

Device Problem High impedance (1291)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the patient experienced ineffective therapy.Diagnostics revealed high impedances on the t12 lead.As such, surgical intervention may take place to address the issue.

• 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: 19138867
• MDR Text Key: 340563268
• Report Number: 1627487-2024-08212
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: (01)05415067027153(10)9220227(17)250510
• 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: 04/18/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MN10450-50A
• Device Lot Number: 9220227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2023
• 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; DRG LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 82 KG