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

Model Number MN10450-50A

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

Event Description

Related manufacturer report numbers 1627487-2020-33106, 1627487-2020-33107, 1627487-2020-33108.It was reported that during an elective explant, 3 of the leads were explanted normally, but the physician had difficulty explanting the fourth lead.A hemilaminectomy was performed to explant the last lead.During the procedure, a dural tear occurred.Following the procedure, the patient did not show any symptoms of a dural tear and is doing well.Note: as it is unknown which lead caused the csf leak, all leads are being reported.

• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10757130
• MDR Text Key: 213838721
• Report Number: 1627487-2020-33109
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2020

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 Expiration Date: 12/03/2020
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 6762434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2018
• 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
• Patient Weight: 98