MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE; DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	6947M72
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	02/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient's cardiac resynchronization therapy defibrillator (crt-d) system was explanted due to the patient's wound "not closing".It was also reported that the surgeon noted the pocket did not appear to be infected.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO SECURE
• Common Device Name: DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6470003
• Report Number: 2649622-2017-04520
• Device Sequence Number: 18980534
• Product Code: NVY
• UDI-Device Identifier: 00643169309739
• UDI-Public: 00643169309739
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2017

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: 04/18/2017
• Device Model Number: 6947M72
• Device Catalogue Number: 6947M72
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2017
• Supplement Date Received by Manufacturer: 02/11/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: DTBA1QQ CRTD, 429888 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR