MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 90CM IMPLANT LEAD KIT, SLIM TIP; DRG LEAD

Model Number MN10450-90A

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Device 2 of 2.Reference mfr.Report#: 1627487-2018-13217.It was reported that the patient experienced ineffective stimulation with their drg system due to high impedance values on all contacts reportedly, x-rays were taken yielding normal results.Reprogramming could not resolve the issue.As a result, surgical intervention is pending to address the issue.

Event Description

Device 2 of 2.Reference mfr report#: 1627487-2018-13217.

• Brand Name: 90CM IMPLANT LEAD KIT, SLIM TIP
• Type of Device: DRG 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: 8178441
• MDR Text Key: 130779702
• Report Number: 1627487-2018-13218
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067027160
• UDI-Public: 05415067027160
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2020
• Device Model Number: MN10450-90A
• Device Lot Number: 6306898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2018
• 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
• Treatment: MODEL: MN10450-90A, DRG LEAD
• Patient Outcome(s): Other