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

Model Number MN20450-50A

Device Problems Break (1069); Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

B3-date of event is estimated.Additional components potentially involved in the event: common device name: drg: lead, model: mn20450-50a, udi: (b)(4), serial: (b)(6), batch: 8830806.Common device name: drg: lead, model: mn20450-50a, udi: (b)(4), serial: (b)(6), batch: 8892605.

Event Description

It was reported that patient experienced ineffective therapy.Attempts to reprogram were unsuccessful.Imaging showed that one lead was broken.Surgical intervention may take place to address the issue.The investigation was unable to determine the lead that was broken.

Manufacturer Narrative

The report event of slim tip broken was not confirmed.As received, microscopic inspection showed the returned lead slim tip no anomalies/damage was found.The cause of the reported event remains unknown.The report event of high impedances was not confirmed.As received, electrically tested showed the returned both terminal ends segments were passed isolation resistant testing.The cause of the reported event remains unknown.".

Event Description

Additional information received identified that patient underwent surgical intervention wherein, the lead was explanted and replaced.Effective therapy was restored post operatively.

• 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: 17999828
• MDR Text Key: 326445492
• Report Number: 1627487-2023-05049
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MN20450-50A
• Device Lot Number: 8472785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2022
• 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 LEAD X2
• Patient Outcome(s): Other
• Patient Sex: Female