MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SYNCRA CRT-P; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	C2TR01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: (b)(4) lead, implanted: (b)(6) 2014; 310c33 tissue valve, implanted: (b)(6) 2007.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient had a sepsis infection of an unknown source.Blood cultures taken were positive for candida parapsilosis and coagulase negative staphylococcus.The device and leads were explanted and not replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCRA CRT-P
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 9350804
• Report Number: 9614453-2019-03921
• Device Sequence Number: 2973348
• Product Code: NVZ
• UDI-Device Identifier: 00613994753304
• UDI-Public: 00613994753304
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/28/2014
• Device Model Number: C2TR01
• Device Catalogue Number: C2TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5076-58 LEAD, 5071-35 X 2 LEADS
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 100