FDA Adverse Event Death Summary report: N

UNK

MDR report key: 855514 · Received May 24, 2007

Report

Report Number
MW5001946
Event Type
Death
Date Received
May 24, 2007
Date of Event
April 24, 2007
Report Date
May 24, 2007
Manufacturer
UNK
Product Code
MQP
Report Source
Voluntary report
Reporter Location
NV, US

Narratives

Description of Event or Problem · 1

REPORTER HAS LIMITED INFORMATION REGARDING DEVICE, BUT HAS PAID TO RECEIVE HER MOTHER'S MEDICAL RECORDS AND SHE SHOULD SOON HAVE MORE INFORMATION. ESSENTIALLY, THE PATIENT HAD 3 FRACTURES OF THE SPINE. TWO YRS PREVIOUSLY, SHE HAD SURGERY TO THE SAME . DAUGHTER AUTHORIZED SURGEONS TO DO A VERTEBROPLASTY, AS SHE WAS TOLD THAT THE PROCEDURE WOULD ENABLE HER MOM TO WALK AGAIN. AND SHE WAS MADE TO BELIEVE THAT FEW, IF ANY COMPLICATIONS WERE ASSOCIATED WITH THE SURGERY. SHE NOW FEELS THAT THE ADVERSE EFFECTS OF THE SURGERY MUST BE UNDERREPORTED. HER MOTHER SPENT 2 WEEKS POST OPERATIVELY, AFTER SURGERY WITH CHRONIC BACK PAIN; AND 4 WEEKS POSTOPERATIVELY, SHE WAS DIAGNOSED DIVERTICULITIS (WHEN SHE DEVELOPED RIGHT LOWER QUADRANT PAIN). THE PATIENT WAS PLACED ON ANTIBIOTICS AT HOSPITAL FOR 2WEEKS. BUT WITHIN 48 HOURS, SHE BEGAN TO DETERIORATE AND THE DOCTORS FELT SHE WOULD SOON DIE. SHE, THE REPORTER, TOOK HER MOM HOME, BUT SHE (HER MOM) CONTINUED TO SUFFER WITH PAIN IN HER BACK, BUT LIVED 3 WEEKS PRIOR TO HER DEATH. REPORTER STATES THAT MEDICAL HISTORY REGARDING HER MOTHER'S SURGERY WILL BE OBTAINED FROM HER MEDICAL RECORDS THAT ARE STORED. SHE IS AWAITING THE ARRIVAL OF THE RECORDS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNK ARTIFICIAL VERTEBRAL DEVICE MQP UNK

Patients

Seq Age Sex Outcome Treatment
1 95 YR Death