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

Model Number MN20450-50A

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

Event date is estimated.

Event Description

It was reported a cerebrospinal fluid (csf) occurred while the physician was placing a lead.The lead was explanted, and the patient is now stable and discharged.

Manufacturer Narrative

Conclusion: the report event of subdural punction was not confirmed.As received, visual inspection demonstrated no damage noted the lead was in one piece and had no marks on it, other than the kink found on the lead body.The cause of the event is consistent with damage during use.

• 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
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16526387
• MDR Text Key: 311126754
• Report Number: 1627487-2023-01061
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: MN20450-50A
• Device Lot Number: 7795773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• 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