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

Model Number MN10350-50A

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

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 05/03/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

It was reported the patient was undergoing a drg trial when the patient experienced pain along the l3 dermatome track the day following implant.Mapping revealed motor stimulation, so the physician opted to explant the l3 lead on (b)(6) 2019 while leaving the l4 trial lead implanted.The patient¿s pain associated with the l3 lead has since resolved.

• Brand Name: 50CM TRIAL LEAD KIT, SLIM TIP
• Type of Device: DRG LEAD
• 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: 8624381
• MDR Text Key: 145521579
• Report Number: 1627487-2019-05854
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025517
• UDI-Public: 05415067025517
• 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,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2019
• Device Model Number: MN10350-50A
• Device Catalogue Number: MN10350-50A
• Device Lot Number: AB2350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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