MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3286

Device Problem Disconnection (1171)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 11/13/2018

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr report: 1627487-2018-12507, reference mfr report: 1627487-2018-12718.It was reported that the patient experienced overstimulation due to invalid impedances.X-rays were taken and confirmed one of the leads had pulled out of the header.Surgical intervention was taken on (b)(6) 2018 to reconnect the leads and ipg.Issue has been resolved.

• Brand Name: LAMITRODE S-8 LEAD KIT, 60CM LENGTH
• Type of Device: SCS 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: 8135011
• MDR Text Key: 129385846
• Report Number: 1627487-2018-12506
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067017833
• UDI-Public: 05415067017833
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 3286
• Device Lot Number: 5222320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2015
• 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: 3716, SCS IPG; SCS LEAD
• Patient Outcome(s): Other