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

Model Number 1194

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/17/2024

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.

Event Description

Related manufacturer reference number: 3006705815-2024-01063 and 1627487-2024-00711.It was reported that the patient's anchors have pulled lose and the lead migrated.The patient coughed very hard and the physician thinks this attributed to the anchor issue.Surgical intervention took place where the lead and anchors were explanted and replaced to address the issue.The ipg was electively replaced effective stimulation was restored.

Manufacturer Narrative

Date of event estimated.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• 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: 18682290
• MDR Text Key: 335069912
• Report Number: 1627487-2024-00710
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1194
• Device Lot Number: 8781761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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 ADAPTERS (X2); SCS IPG
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 73 KG