MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXCLAIM LEAD, 90 CM; SCS LEAD

Model Number 3225

Device Problem Disconnection (1171)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

St.Jude medical 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.Sjm defers to the patient's physician regarding medical history.

Event Description

The patient reported he suffered a seizure approximately 3-4 weeks ago and he began experiencing difficulty with his scs system.The patient has 2 scs systems implanted and the issue is with the cervical system.The patient began experiencing pain and unintended stimulation outside of his normal covered areas.The patient went to the er where an x-ray was taken and showed one of the leads may be loose.The patient has turned off the scs system.Surgical intervention may be pending to address this issue.

Event Description

Related manufacturer reference number: 3006705815-2019-03563, 3006705815-2019-03564.It was reported that the patient had their cervical system explanted on (b)(6) 2018.

• Brand Name: EXCLAIM LEAD, 90 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
• MDR Report Key: 6815054
• MDR Text Key: 83455391
• Report Number: 1627487-2017-04614
• 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
• Report Date: 09/24/2019

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: 04/30/2018
• Device Model Number: 3225
• Device Lot Number: 5509280
• Other Device ID Number: 05415067017758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 47 YR