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

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/14/2016

Event Type  Injury  

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.

Event Description

Device 1 of 2.Reference mfr report: 1627487-2017-01629.It was reported ((b)(6)) the patient underwent a revision surgery on (b)(6) 2016, where the leads were reconnected.Device information and quantity is unknown for the patient¿s leads.

Event Description

Device 1 of 2.Reference mfr report: 1627487-2017-01629.Additional information received identified prior to revision surgery on (b)(6) 2016, radioscopy confirmed one of the patients leads was disconnected.

• Brand Name: LEAD
• 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: 6444291
• MDR Text Key: 71200570
• Report Number: 1627487-2017-01628
• 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: 04/14/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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