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	08/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4024-58 lead, implanted: (b)(6) 1995.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) and leads were explanted due to pocket infection.It was noted that the leads eroded through skin and were visible outside body.Cultures were taken.Antibiotic treatment was necessary.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
4004m58 lead, implanted (b)(6) 1992.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: 8971936
• Report Number: 9614453-2019-02985
• Device Sequence Number: 2560016
• Product Code: NVZ
• UDI-Device Identifier: 00613994753304
• UDI-Public: 00613994753304
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 09/10/2019

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: Lay User/Patient
• Device Expiration Date: 06/28/2012
• Device Model Number: C2TR01
• Device Catalogue Number: C2TR01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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: 77 YR