MAUDE Adverse Event Report: MEDTRONIC, INC. TRANSVENOUS LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6707-35
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and analyzed but no issue was identified that required full analysis.Analysis was performed and no anomalies were found.Concomitant medical products: 0041 boston scientific lead, implanted: (b)(6) 1993; 383059 lead, implanted: (b)(6) 2010; 4047 boston scientific lead, implanted: (b)(6) 2012; 6721l-50 lead, implanted: (b)(6) 2012; d143 boston scientific icd, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the lead was explanted due to a malfunction of the connector.The lead was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis the distal portion of the lead was returned, analyzed.Analysis indicated that the right ventricular defibrillation coil developed a fracture due to flexing while in vivo.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRANSVENOUS LEAD
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8064410
• Report Number: 2182208-2018-02064
• Device Sequence Number: 2418479
• Product Code: LWS
• UDI-Device Identifier: 00681490148450
• UDI-Public: 00681490148450
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: Lay User/Patient
• Device Expiration Date: 04/14/2012
• Device Model Number: 6707-35
• Device Catalogue Number: 6707-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 39 YR