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

Model Number MN10450-50A

Device Problems Break (1069); Patient-Device Incompatibility (2682)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/04/2021

Event Type  Injury  

Event Description

Related manufacturer reference number 1627487-2021-02089, 1627487-2021-02090.It was reported that during a lead revision, the leads were scarred in too much causing lead fragment in the patient's body.As a result, the system was explanted to address the issue.

Manufacturer Narrative

The drg system was explanted due to a patient issue.Per event details, the drg system was explanted due to the patient not wanting to use the patient controller (pc).The lead was received incomplete with only the terminal end lead segment (26.0cm) and the middle segment (13.0cm) being returned.The lead was missing channel 1 terminal end electrode.The missing terminal end electrode was stuck in the ipg header.The detached lead terminal end electrode occurred during the explant procedure.The lead was damaged beyond functional testing.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11496301
• MDR Text Key: 240088037
• Report Number: 1627487-2021-02088
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2021
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 6840447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG IPG; DRG SLIM TIP LEAD; DRG IPG; DRG SLIM TIP LEAD
• Patient Outcome(s): Other
• Patient Weight: 52