MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	D314TRM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial reported event was received on [2016-09-13].Of note, the reportable malfunction and/or serious injury [infection] is normally submitted via a bimonthly report submission that would have been due on submission [2016-10-13].Information was subsequently received on [2019-03-08] and revealed [serious injury].As there is new information that reasonably suggests the device has or may have caused or contributed to a [serious injury], this event no longer qualifies for bimonthly reporting and is therefore being submitted as a 30-day report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the device incision site was reddened and swollen.The patient had a superficial incision site infection.The patient was hospitalized and treated with iv antibiotics.The infection has not resoslved and will continue on antibiotics for 6 weeks.Further actions/treatments are planned.The device remains in use.No further patient complications have been reported as a result of this event.2016-11-17: additional information was received that the patient was discharged home on oral antibiotics and the infection resolved.No further patient complications have been reported as a result of this event.2019-03-18: the patient is a participant in the post approval clinical surveillance product surveillance registry.

• Brand Name: PROTECTA XT CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8429018
• Report Number: 3004209178-2019-05469
• Device Sequence Number: 13860027
• Product Code: NIK
• UDI-Device Identifier: 00613994714589
• UDI-Public: 00613994714589
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: 09/14/2013
• Device Model Number: D314TRM
• Device Catalogue Number: D314TRM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2016
• Initial Report FDA Received Date: 03/18/2019
• 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: 6947M62 LEAD, 419688 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR