MAUDE Adverse Event Report: ABBOTT MEDICAL LEAD ANCHOR, BUTTERFLY; ACCESSORY

Model Number	1105
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional 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. .
Event or Problem Description
It was reported that during a system explant procedure on (b)(6) 2021 [related manufacturer reference numbers: 3006705815-2021-05318 & 3006705815-2021-05317], the physician was unable to find a butterfly anchor that had been implanted and decided to not waste time looking for it; therefore, a butterfly anchor remains implanted.

• Brand Name: LEAD ANCHOR, BUTTERFLY
• Common Device Name: ACCESSORY
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12724314
• Report Number: 1627487-2021-17947
• Device Sequence Number: 4028693
• Product Code: LGW
• UDI-Device Identifier: 05414734400046
• UDI-Public: 05414734400046
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1105
• Device Catalogue Number: 1105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Weight: 54