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

Model Number 3286

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

Device 3 of 3.Reference mfr report#1627487-2018-08820, reference mfr report: 1627487-2018-08819.It was reported that the patient underwent surgical intervention on (b)(6) 2018 for high impedance.Where both extensions and lead model 3286 were inadvertently cut.As a result, lead model 3186 and a new extension were connected to the ipg.Effective therapy has not been established.A follow up is pending.

Event Description

Device 3 of 3.Reference mfr report#1627487-2018-08820.Reference mfr report: 1627487-2018-08819.Follow up revealed that the patient currently has therapy.No additional surgery is planned at this time.

• 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: 8164944
• MDR Text Key: 130356888
• Report Number: 1627487-2018-12261
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup,Followup
• Report Date: 02/22/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2010
• Device Model Number: 3286
• Device Lot Number: 175112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 12/18/2018; 01/29/2019
• Supplement Dates FDA Received: 01/11/2019; 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2008
• 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: 3386, EXTENSION (2)
• Patient Outcome(s): Other