MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number	2088TC/100
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unspecified issue.
Event or Problem Description
It was reported that the right ventricular lead was implanted and explanted the same day for unspecified reasons.No patient symptoms or additional information was reported.
Additional Manufacturer Narrative
Based on new information received the lead was never used/implanted.The physician after opening the lead package thought the lead was too long and was not used.As a result, the mdr report should be retracted.Final analysis found normal lead characteristics.
Event or Problem Description
New information reported on (b)(6) 2018 revealed that the physician opened the lead package but was not used because the physician thought it was too long and was not used and replaced.This deems this a non reportable event.

• Brand Name: TENDRIL STS
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7762083
• Report Number: 2017865-2018-11191
• Device Sequence Number: 11153262
• Product Code: NVN
• UDI-Device Identifier: 05414734505031
• UDI-Public: 05414734505031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 2088TC/100
• Device Lot Number: P000058651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 08/17/2018
• 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: Required Intervention