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

Model Number MN10450-50A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

The allegation is against 1 of 3 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: drg slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 9023672.Common device name: drg slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 9023672.

Event Description

It was reported that a few days after a lead replacement procedure, the patient reported a headache due to a csf leak and surgical intervention was undertaken on (b)(6) 2023 wherein a blood patch occurred.Follow up indicated the patient was doing well postoperatively and their headache resolved.

Manufacturer Narrative

The results of the investigation are inconclusive as the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• 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: 17393079
• MDR Text Key: 319744602
• Report Number: 1627487-2023-03555
• 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,Followup
• Report Date: 08/23/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: MN10450-50A
• Device Lot Number: 8867149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2023
• 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 X 2
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 50 KG