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

Model Number 1194

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

Patient Problems Increased Sensitivity (2065); Weight Changes (2607)

Event Date 09/16/2014

Event Type  Injury  

Event Description

It was reported the pt experienced soreness between her shoulder blades due to the scs anchor being superficial.Also, the pt has lost weight.Surgical intervention will be taken at a later date to address the issue.The pt received 2 scs anchors with the same lot number.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: CINCH ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: taruna sharma ; 6901 preston rd.; plano, TX 75024 ; 9725269635
• MDR Report Key: 4249605
• MDR Text Key: 5047719
• Report Number: 1627487-2014-20400
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: 1194
• Device Lot Number: 3439246
• Other Device ID Number: 05414734400688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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: IMPLANT DATE:; SCS IPG: MODEL 3788; SCS LEAD: MODEL 3228; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 57 YR