MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S8; SCS LEAD

Model Number 3286

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/18/2014

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr reports: 1627487-2014-06189, 06190.The patient has two leads implanted with the same lot number.Information received identified the patient experienced excessive heat while recharging and device would shock her upon sudden movement.Patient had a nerve block procedure performed in the later half of 2012 and patient was jerking so uncontrollably from the device during the procedure that a sjm representative had to be called in to turn down the device.The patient has stopped using her scs system and had a pain pump implanted.On 08/01/2012 st.Jude medical, neuromodulation division, sent field action letters to patient related to heating while charging and raised awareness of this issue to patients.An increase in prior non-reported heating while charging events and other non-reported events was expected.

Manufacturer Narrative

Sjm 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.

• Brand Name: LAMITRODE S8
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: kimberly goode ; 6901 preston rd.; plano, TX 75024 ; 9723098541
• MDR Report Key: 3976370
• MDR Text Key: 4631966
• Report Number: 1627487-2014-06188
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Model Number: 3286
• Device Lot Number: 3690037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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
• Treatment: SCS ANCHOR: MODEL 1192 (2); IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 40 YR