MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXCLAIM LEAD, 60 CM; SCS LEAD

Model Number 3224

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

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

Event Date 05/31/2018

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 1 of 2.Reference mfr.Report: 1627487-2018-05936.It was reported the patient experienced ineffective stimulation despite reprogramming.The patient had two falls several months ago.A drg trial is planned at a future date.

Event Description

Device 1 of 2: reference mfr.Report: 1627487-2018-05936.

Event Description

Device 1 of 2: reference mfr.Report: 1627487-2018-05936.Follow-up identified the patient underwent a drg trial on (b)(6) 2018 which yielded positive results.The plan is to undergo a permanent drg procedure.

Event Description

Device 1 of 2: reference mfr.Report: 1627487-2018-05936.Follow-up identified the patient underwent a drg system implant on (b)(6) 2018.The patient has effective stimulation following the procedure.No intervention was performed on the reported scs system.

• Brand Name: EXCLAIM LEAD, 60 CM
• 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: palka sharma ; 9725264823
• MDR Report Key: 7635815
• MDR Text Key: 112273253
• Report Number: 1627487-2018-05935
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 3224
• Device Lot Number: 3624126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2012
• 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
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 68