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

Model Number D334TRG

Device Problem Insufficient Information (3190)

Patient Problems Cardiomyopathy (1764); Death (1802); Heart Failure (2206)

Event Date 06/20/2014

Event Type  Death  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

An implantable cardiac defibrillator (icd) system was returned to the manufacturer from a mortuary with information indicating the patient is deceased.Further review of the manufacturer¿s database indicated the patient is deceased and died approximately two years, six months after device replacement.Additional information provided noted the cause of death as: probably arrhythmia or automatic internal device failure, systolic heart failure and viral cardiomyopathy.Additional information related to the circumstances of the death and related to the statement of device failure has been requested and not received.

Manufacturer Narrative

Additional information was received from the physician.The circumstances surrounding the death was noted as: cardiac arrest.It was unknown if a device check was performed at the time of death and if there were any performance issues present.The patient was reported to have worsening cardiomyopathy.No autopsy was performed and it was unknown if there was a relationship between the device system and the patient death.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTECTA CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 4023308
• MDR Text Key: 12423781
• Report Number: 3004209178-2014-15573
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2012
• Device Model Number: D334TRG
• Device Catalogue Number: D334TRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5076-45 LEAD, 4193-88 LEAD, 6947-58 LEAD
• Patient Outcome(s): Death
• Patient Age: 00049 YR
• Patient Weight: 136