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

Model Number 1194

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

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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 1 of 2.Reference mfr report: 1627487-2018-03704.It was reported that the patient's anchor was eroding through the skin.As result, the patient's system was explanted to prevent an infection.Note: it is unknown which anchor is liable, as such both are being reported.

• Brand Name: CINCH LEAD ANCHOR
• Type of Device: SCS ANCHOR
• 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: 7424552
• MDR Text Key: 105240823
• Report Number: 1627487-2018-03703
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 1194
• Device Catalogue Number: 1194
• Device Lot Number: 5197101
• Other Device ID Number: 05414734400688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• 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
• Treatment: MODEL: 3189 SCS, LEAD (2); MODEL: 3662, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 45 YR