MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SCS ACCESSORY KIT STERILE

Model Number 1701

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported during the scs system explant (reference mfr.Report#1627487-2019-00648) the physician was unsuccessful with placement of the introducer over the existing lead in an attempt to replace the device.As a result, the case was abandoned.

• Brand Name: SCS ACCESSORY KIT STERILE
• Type of Device: SCS ACCESSORY KIT STERILE
• 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: 8239367
• MDR Text Key: 132773533
• Report Number: 1627487-2019-00642
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734401708
• UDI-Public: 05414734401708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050922
• 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,Followup
• Report Date: 02/20/2019

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: 07/26/2019
• Device Model Number: 1701
• Device Lot Number: 6061209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2017
• 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: 68