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

Model Number MN10350-50A

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 03/31/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2021-13351.It was reported the patient had fluid coming from the lead site.As a result surgical intervention was undertaken to explant the leads.During the procedure it was noted the patient had a csf leak causing the issue.Surgical intervention resolved the issue.

Manufacturer Narrative

It was reported to abbott that during the patient¿s trial lead implant procedure the patient experienced a cerebral spinal fluid leak.The patient leads were explanted.The results of the investigation are inconclusive since the leads were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: KIT TRIAL SLIM TIP LEAD, 50CM
• Type of Device: DRG TRIAL SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11695868
• MDR Text Key: 246444280
• Report Number: 1627487-2021-13350
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027139
• UDI-Public: 05415067027139
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2021
• Device Model Number: MN10350-50A
• Device Catalogue Number: MN10350-50A
• Device Lot Number: 7298766
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: MN10350-50A , DRG TRIAL SLIM TIP LEAD
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 75