MAUDE Adverse Event Report: ABBOTT MEDICAL CINCH LEAD ANCHOR; SCS ANCHOR

Model Number 1194

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

Patient Problem Implant Pain (4561)

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

Date of event estimated.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The allegation is against 1 of 2 anchor; however, it is unknown which anchor(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: anchor, model: 1194ans, udi: (b)(4), serial: n/a, batch: 6192367.

Event Description

Related manufacturer reference number: 1627487-2023-05904.It was reported that the patient was experiencing discomfort at the ipg and anchor site.Surgical intervention took place where the ipg and anchor were explanted and replaced to address the issue.Effective stimulation was restored.Investigation was unable to determine which of the anchors attributed to the event.The allegation is against 1 of 2 anchor; however, it is unknown which anchor(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: anchor, model: 1194ans, udi: (b)(4), serial: n/a, batch: 6192367.

• Brand Name: CINCH LEAD ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18320685
• MDR Text Key: 330401655
• Report Number: 1627487-2023-05905
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024091
• UDI-Public: 05415067024091
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2023

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: 11/22/2019
• Device Model Number: 1194
• Device Lot Number: 6192367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• 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: SCS ANCHOR; SCS LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 91 KG