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

Model Number 1194

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

Additional components potentially involved in the event include: common device name: scs anchor, model: 1194 , udi: (b)(4), serial:/na, batch: (b)(6).

Event Description

Related manufacturer reference number: 1627487-2023-05283, related manufacturer reference number: 1627487-2023-05284, related manufacturer reference number: 1627487-2023-05285.It was reported that the patient experienced shocking sensation at the ipg site on tonic program mode.X-rays confirmed that both the leads and one of the anchors have migrated.Additionally, the patient is no longer getting effective therapy.As such, surgical intervention may take place at a later date to address the issue.Investigation was unable to determine which of the anchors migrated.

Event Description

Additional information received indicates that surgical intervention took place on (b)(6) 2023 wherein the entire system was explanted to address the issues.

Manufacturer Narrative

The report of migration can not be confirmed through lab analysis.Analysis of the returned anchors (x2) found no physical anomalies.

• 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: 18106987
• MDR Text Key: 327866648
• Report Number: 1627487-2023-05287
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024091
• UDI-Public: 05415067024091
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: 1194
• Device Lot Number: 8028425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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
• Patient Outcome(s): Other