MAUDE Adverse Event Report: ABBOTT TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number	2088TC/100
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product is registered as a combination product.The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During the implant procedure, the guidewire would not advance down the lumen of the left ventricular (lv) lead.A new lv lead was used to resolve the event.The patient was stable with no consequences.
Additional Manufacturer Narrative
As received, a complete lead was returned in one piece.Visual inspection of the lead did not reveal any anomalies.Analysis found the stylet to be obstructed by blood.Electrical testing did not reveal any indication of conductor fractures or internal shorts.The cause of the reported event was due to blood obstructing the stylet in the inner coil.

• Brand Name: TENDRIL STS
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10285651
• Report Number: 2017865-2020-09341
• Device Sequence Number: 14123128
• Product Code: NVN
• UDI-Device Identifier: 05414734505031
• UDI-Public: 05414734505031
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 2088TC/100
• Device Catalogue Number: 2088TC-100
• Device Lot Number: P000101343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1