MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 4 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3240

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Staphylococcus Aureus (2058); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Device 2 of 2.Reference mfr report: 1627487-2016-03364.It was reported (france) x-rays noted the patient's ons leads were disconnected from the ipg header.The patient underwent surgical intervention (date unknown) where the physician attempted to reconnect the leads into the ipg header; however the ipg header set screw would not tighten.The physician decided to reinsert the lead into the header and close the pocket without tightening the set screw.After 3 weeks, the patient developed an infection.The patient underwent surgical intervention (date unknown) where the physician explanted the ipg.It is unknown if the lead was left implanted.Additional information has been requested; however it is unavailable at this time.

Event Description

Additional information received indicates patient was hospitalized and antibiotics were prescribed to treat the staphylococcus aureus infection at the ipg site.During the ipg explant procedure while removing the infected part the physician pulled the lead to the neck area.The patient experienced bulge at the neck and at the scar on the shoulder.Blood test revealed increased crp (c-reactive protein test).The patient was diagnosed with staphylococcus infection and purulent wound at the lead site.As a result, the lead was explanted on (b)(6) 2016 to address the issue.Reportedly, the infection was resolved in end of (b)(6) 2016.

• Brand Name: LAMITRODE 4 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: 5777328
• MDR Text Key: 49020456
• Report Number: 1627487-2016-03365
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

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: 01/31/2017
• Device Model Number: 3240
• Device Lot Number: 4998650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/07/2016
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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