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

Model Number	D314TRG
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5071-53 lead, implanted: (b)(6) 2009; 0125 lead, implanted: (b)(6) 1997.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a device generator change procedure for suspected premature battery depletion, when opening the pocket a left ventricular (lv) lead insulation tear occurred.The lv lead was "repaired" with a suture sleeve and was kept as the active lv lead.Approximately three years later, the lv lead exhibited low impedance and high threshold.A procedure was scheduled to attempt additional lead placement.During the procedure it was noted via angiogram that an obstruction of the ostium of the sinus was present likely from a slip-like appearance as the right atrium is markedly dilated.As such, multiple attempts to access the coronary sinus were unsuccessful and the procedure was abandoned.The physician then focused on approach to the lv epicardial lead.It was noted that the suture sleeve around the area of the lv epicardial lead was damaged, and was removed.The site was then covered with sealant, the cap was cut around the damaged area and the area was sealed off with several sutures.The lv epicardial lead was tested and showed improved and acceptable lead impedance values.The lv lead remains in use.No patient complications have been reported as a result of this event.

• 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: 11146788
• Report Number: 3004209178-2021-00485
• Device Sequence Number: 17016330
• Product Code: NIK
• UDI-Device Identifier: 00613994677884
• UDI-Public: 00613994677884
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2021

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: 07/28/2014
• Device Model Number: D314TRG
• Device Catalogue Number: D314TRG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 01/11/2021
• 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: 4054 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR