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

Model Number	D284TRK
Medical Device Problem Codes	Mechanical Problem (1384); Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4196 lead implanted (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right ventricular (rv) lead exhibited irregular and inconsistent impedance on both defibrillation coils as seen through the cardiac resynchronization therapy defibrillator (crt-d), possibly due to impending fracture.The crt-d was explanted and replaced.Multiple impedance measurements were taken through the new device and were within normal limits.The physician requested confirmation of a header issue with the replaced device.It was also reported that rising impedance was observed on the right atrial (ra) lead.No action was taken and the lead remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAXIMO II 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: 7642454
• Report Number: 3004209178-2018-14468
• Device Sequence Number: 2482335
• Product Code: NIK
• UDI-Device Identifier: 00613994446916
• UDI-Public: 00613994446916
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2018

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: 02/14/2015
• Device Model Number: D284TRK
• Device Catalogue Number: D284TRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 07/06/2018
• 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: 6947 LEAD, 4574 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR