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 No Consequences Or Impact To Patient (2199)

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 4 of 4.Reference mfr.Report#: 1627487-2018-10148, 1627487-2018-10149, 1627487-2018-10150.It was reported that the patient's scs system was slated to be explanted for reasons currently unknown.

Event Description

Device 4 of 4 reference mfr.Report#: 1627487-2018-10148, 1627487-2018-10149, 1627487-2018-10150.Follow up revealed that the patient elected to have his scs system explanted per own request.

Manufacturer Narrative

Corrected data: follow up identified that this product should not have been reported on in 2018 because there were no alleged deficiencies with the product and there was no intervention undertaken.

• 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
• Manufacturer Contact: michael mccane ; 6901 preston road; plano, TX 75024 ; 9725268297
• MDR Report Key: 7972292
• MDR Text Key: 123934678
• Report Number: 1627487-2018-10151
• 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,Followup,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 1194
• Device Catalogue Number: 1194
• Device Lot Number: 3296540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2011
• 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
• Patient Outcome(s): Other