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

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880)

Event Type  Injury  

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete event, patient and device information.Further information was requested but not received.A patient experienced a cerebrospinal fluid leak during a trial was reported to abbott.It was determined during the drg trial the patient had migraines from spinal fluid leak.The results of the investigation are inconclusive as the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

Event Description

It was reported that the patient experienced a cerebral spinal fluid leak during a drg trial procedure.The patient reported experiencing migraines following the procedure.

• Brand Name: DRG SLIM TIP LEAD
• Type of Device: DRG TRIAL 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: 18661213
• MDR Text Key: 334788102
• Report Number: 1627487-2024-00672
• Device Sequence Number: 1
• Product Code: PMP
• 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: Other
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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