FDA Adverse Event Death Summary report: N

SENSIA SR

MDR report key: 1890305 · Received November 3, 2010

Report

Report Number: 2647346-2010-00712
Event Type: Death
Date Received: November 3, 2010
Date of Event: August 27, 2010
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: NVZ
PMA / PMN Number: P980035/S043
Removal / Correction Number: ASKU
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT DIED. THE RELATEDNESS OF THE DEATH TO THE DEVICE SYSTEM WAS REPORTED AS "UNKNOWN". THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT DIED. THE RELATEDNESS OF THE DEATH TO THE DEVICE SYSTEM WAS REPORTED AS "UNKNOWN". THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH THE CLINIC REPORTED PATIENT HAD BAD FALL AND WAS HOSPITALIZED FOR 4 DAYS THE MONTH PRIOR TO DEATH FOR FRACTURED RIGHT RIBS AND HEMOTHORAX. PATIENT ACQUIRED MRSA IN THE HOSPITAL AND WAS TREATED WITH ANTIBIOTICS. DISCHARGED TO A NURSING HOME. PATIENT WAS LAST SEEN 9 MONTHS PRIOR TO DEATH FOR STUDY ENROLLMENT AND THERE WERE NO KNOWN PROBLEMS WITH THE DEVICE SYSTEM AT THAT TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SENSIA SR	IMPLANTABLE PULSE GENERATOR	NVZ	MEDTRONIC MED REL, INC.	SESR01	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR		Death\| H\| L\| R