MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD

Model Number 3219

Device Problem Break (1069)

Patient Problem 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 3.Reference mfr report: 1627487-2018-00789.Reference mfr report: 1627487-2018-00791.It was reported that the patient developed drainage at their ipg site.As a result, their physician gave them antibiotics and applied a dressing.The week following, the drainage continued so a different antibiotic was administered.The patient followed up with their physician and black drainage was noticed, as well as the ipg eroding through the skin.No cultures were taken.As a result, the patient's ipg was explanted on (b)(6) 2018.During the procedure the patient's leads were cut, but remain implanted.Surgical intervention could be pending to remove the leads.

• Brand Name: LAMITRODE TRIPOLE 16 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
• MDR Report Key: 7219935
• MDR Text Key: 98250758
• Report Number: 1627487-2018-00790
• 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: Other
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 3219
• Device Lot Number: 4269639
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2013
• 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: 61 YR
• Patient Weight: 103