MAUDE Adverse Event Report: ABBOTT MEDICAL CINCH LEAD ANCHOR

Model Number 1194

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

Patient Problem Erosion (1750)

Event Date 12/05/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Additional components potentially involved in the event include: common device name: cinch lead anchor, model: 1194, udi: (b)(4) batch: 5345393.

Event Description

Related manufacturer reference number: (b)(4).It was reported that the patient recently lost weight, their anchors were poking out, and lead had high impedances.Surgical intervention may be undertaken at a later date to address the issue.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

Manufacturer Narrative

E1 correction: the reporter's information was updated.

Event Description

Related manufacturer reference number: (b)(4).Surgical intervention was undertaken on (b)(6) 2024 wherein the entire system was explanted and replaced to address the issue.Therapy was restored post procedure.

Manufacturer Narrative

D10 correction: this was updated to reflect medical product implanted.

• Brand Name: CINCH LEAD ANCHOR
• Type of Device: 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: 18399062
• MDR Text Key: 331401527
• Report Number: 1627487-2023-06127
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400688
• UDI-Public: 05414734400688
• 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,Followup,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 1194
• Device Lot Number: 5345393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2016
• 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: ANCHOR.; SCS IPG.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 59 KG