MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/4MM, 60 CM; SCS LEAS

Model Number 3146

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

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported the patient is experiencing lead migration.Subsequently, the patient will undergo surgical intervention as the next course of action.No further information is known at this time.The event date is unknown.

Event Description

The patient had 2 leads from same lot implanted as part of her scs system.Follow-up information revealed the patient underwent surgical intervention where the leads were explanted and replaced with a different model.It was noted the patient's leads were damaged.In addition, during the procedure, the physician electively explanted and replaced the patient's ipg.

• Brand Name: QUATTRODE LEAD, 3/4MM, 60 CM
• Type of Device: SCS LEAS
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston road; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston road; plano TX 75024
• MDR Report Key: 5336266
• MDR Text Key: 34734703
• Report Number: 1627487-2015-23758
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2006
• Device Model Number: 3146
• Device Lot Number: 28341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2004
• 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