MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 50CM SLIMTIP IMPLANT LEAD KIT; DRG SLIM TIP LEAD

Model Number MN10450-50A

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Dyspnea (1816); Headache (1880)

Event Date 10/06/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 1627487-2019-11975.It was reported the patient experienced headaches and trouble breathing due to a csf leak following implant of trial leads.As a result the leads were explanted on an unknown date and a blood patch was performed.Symptoms have resolved.

Manufacturer Narrative

Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 1627487-2019-119.

• Brand Name: 50CM SLIMTIP IMPLANT LEAD KIT
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 9240692
• MDR Text Key: 163806827
• Report Number: 1627487-2019-11976
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2021
• Device Model Number: MN10450-50A
• Device Lot Number: 6820292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2019
• 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 LEAD
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 113