MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SENSIA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SEDR01

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 11/21/2014

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported by the patient¿s wife that the patient was deceased.The caller inquired if any episodes occurred at the time of death.The caller alleged that the implantable pulse generator (ipg) system caused or contributed to the death.The patient died approximately three years following the implant of the ipg system.A cause of death was not reported.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

No eval explain code.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENSIA DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4362762
• MDR Text Key: 18392668
• Report Number: 3004209178-2014-24551
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/29/2015

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2012
• Device Model Number: SEDR01
• Device Catalogue Number: SEDR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/29/2015
• Supplement Dates FDA Received: 01/21/2015; 01/30/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2011
• 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: 5076-52 LEAD, 5076-58 LEAD
• Patient Outcome(s): Death
• Patient Age: 00059 YR