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

Model Number 3286

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-01871.It was reported that the patient¿s ipg was inoperable and the lead¿s contact plate came off.Additionally, due to patient¿s unrelated health condition the entire system was explanted on (b)(6) 2020 addressing the issue.

Manufacturer Narrative

The reported event of separation was confirmed.As received, the lamitrode was complete.Observed broken and exposed wires at electrode #6, as well as multiple broken wires at the paddle head.The separation and broken wires were consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.(b)(4).The correct information has been updated.

• Brand Name: LAMITRODE S-8 LEAD KIT, 60CM LENGTH
• Type of Device: SCS PADDLE 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: 9745252
• MDR Text Key: 180610606
• Report Number: 1627487-2020-01846
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017833
• UDI-Public: 05415067017833
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 04/08/2020

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: 04/05/2018
• Device Model Number: 3286
• Device Catalogue Number: 3286
• Device Lot Number: 5449977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• 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: SCS IPG
• Patient Outcome(s): Other