FDA Adverse Event Death Summary report: N

PUMP MMT-522LNAL PRDGM INS CL EN ML

MDR report key: 1726188 · Received June 11, 2010

Report

Report Number
2032227-2010-81451
Event Type
Death
Date Received
June 11, 2010
Date of Event
May 6, 2010
Report Date
May 20, 2010
Manufacturer
MEDTRONIC MINIMED
Product Code
LZG
PMA / PMN Number
P980022
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
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

IT WAS STATED THAT THE CUSTOMER PASSED AWAY DUE TO DIABETES COMPLICATIONS. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP IS GOING TO BE DONATED PER THE FAMILY. NOTHING FURTHER WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PUMP MMT-522LNAL PRDGM INS CL EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522LNAL

Patients

Seq Age Sex Outcome Treatment
1 59 YR Death