MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3244

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

Patient Problems Fall (1848); Seizures (2063); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr report: 1627487-2017-07022.It was reported that the patient experienced ineffective therapy.In addition, the patient has a history of seizures and falls.As a result, surgical intervention may be pending to explant the patient¿s scs system.

Event Description

Device 2 of 2.Reference mfr report: 1627487-2017-07022.Follow up revealed that the patient elected to attempt to reprogram their device.The patient was upgraded to burst and will try out their new settings prior to making a decision whether surgical intervention is needed.

Manufacturer Narrative

Date of explant received.

Event Description

Additional information was received patient¿s system was explanted.

Manufacturer Narrative

The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: LAMITRODE 44 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
• MDR Report Key: 7011384
• MDR Text Key: 91385638
• Report Number: 1627487-2017-07023
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2019
• Device Model Number: 3244
• Device Lot Number: 5835363
• Other Device ID Number: 05414734406215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 01/31/2018; 01/17/2020; 02/09/2020
• Supplement Dates FDA Received: 02/23/2018; 02/13/2020; 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• 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
• Treatment: MODEL: 3383, SCS EXTENSION (2); MODEL: 3772, SCS IPG
• Patient Outcome(s): Other