MAUDE Adverse Event Report: ABBOTT MEDICAL DRG SLIM TIP LEAD; DRG LEAD

Model Number NMD0006

Device Problem Naturally Worn (2988)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/01/2023

Event Type  Injury  

Event Description

It was reported that the patient had lost therapy.As a result, the patient underwent surgical intervention during which the system was explanted and replaced with another manufacturer's system.It was noted that the lead was naturally worn during the procedure.

Manufacturer Narrative

Date of event is estimated.Date of implant is unknown.The unique device identifier (udi) is not provided because the device is unknown.Initial reporter phone number: (b)(6).

• Brand Name: DRG SLIM TIP LEAD
• 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: 19199211
• MDR Text Key: 341237840
• Report Number: 1627487-2024-08413
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NMD0006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Sex: Male