FDA Adverse Event Death Summary report: N

PUMP MMT-722NAB PRDGM INS V2.2 BL EN

MDR report key: 1667341 · Received April 19, 2010

Report

Report Number
2032227-2010-80946
Event Type
Death
Date Received
April 19, 2010
Date of Event
January 11, 2010
Report Date
April 1, 2010
Manufacturer
MEDTRONIC MINIMED
Product Code
LZG
PMA / PMN Number
P980022
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

Description of Event or Problem · 1

THE CUSTOMER'S FATHER REPORTED THAT THE CUSTOMER PASSED AWAY AFTER SUFFERING A HYPOGLYCEMIC CEREBRAL INJURY. THE FATHER STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP WHEN HE WAS FOUND. THE MOTHER KEPT THE INSULIN PUMP, AND THE FATHER HAS NO COMMUNICATION WITH HER. NOTHING FURTHER WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PUMP MMT-722NAB PRDGM INS V2.2 BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722NAB

Patients

Seq Age Sex Outcome Treatment
1 40 YR Hospitalization