MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D334DRM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/07/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient is deceased.The patient's spouse called in to inquire what happens to a patient's implantable cardioverter defibrillator (icd) once the patient has passed away.The spouse indicated that the patient was having trouble breathing and they did cardiopulmonary resuscitation (cpr) until the emergency medical technicians (emt's) arrived and continued the cpr and provided the patient medication and "used the paddles" in order to resuscitate the patient.The effort was unsuccessful, and the patient had passed.The spouse alleges the icd contributed to patient death and asked for the device to be interrogated in an effort to tell them what happened.The caller was provided information on how to return the device for analysis.

• Brand Name: PROTECTA DR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 8170067
• Report Number: 3004209178-2018-27811
• Device Sequence Number: 1406348
• Product Code: LWS
• UDI-Device Identifier: 00613994714602
• UDI-Public: 00613994714602
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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: 11/14/2013
• Device Model Number: D334DRM
• Device Catalogue Number: D334DRM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/17/2018
• 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: 6935M62, LEAD / 5076-52, LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 66 YR