FDA Adverse Event Other Summary report: N

PROCLAIM NEUROSTIMULATION SPINAL STIMULATOR

MDR report key: 18058390 · Received November 1, 2023

Report

Report Number
MW5147650
Event Type
Other
Date Received
November 1, 2023
Date of Event
December 1, 2022
Report Date
October 30, 2023
Manufacturer
ABBOTT MEDICAL
Product Code
LGW
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
PATIENT
Health Professional
N

Narratives

Description of Event or Problem · 0

MY PROCLAIM NEUROSTIMULATION SYSTEM WAS REMOTELY ACCESSED, WHEN IT WAS TURNED OFF. I PLACED A SCREEN TIME CODE ON THE APPLE DEVICE THAT CONTROLLED IT. TRYING TO KEEP THE UNAUTHORIZED ¿DEVICE¿ FROM CHANGING THE SETTINGS. I WAS FRANTIC TRYING TO GAIN CONTROL OF MY STIMULATOR AND FORGOT TO WRITE DOWN THE CODE FOR THE SCREEN TIME. APPLE WOULD NOT UNLOCK IT DUE TO THE FACT I COULDN¿T PRODUCE THE ORIGINAL RECEIPT. SINCE THEN, THE BLUETOOTH SIGNAL IS GONE, AND THE BATTERY WOULD HAVE TO BE REPLACED. I HAVE REPORTED THIS TO THE ABBOTT REP AND TO THE TECH DEPT. THE TECH PROFESSIONAL SAID IT WASN¿T POSSIBLE THAT SOMEONE REMOTELY ACCESSED MY IMPLANT. 1.) WE HAD NETWORK INTRUSION. 2.) ALL DEVICES WE REMOTELY ACCESSED. 3.) IT IS POSSIBLE! 4.) MALWARE SPREAD THROUGH MY DEVICES VIA BLUETOOTH. THE MALWARE COULDN¿T HIDE IN THE DEVICE. BUT IT WAS ACCESSED REMOTELY. MY DEVICE WAS NOT FUNCTIONING (APPLE DEVICE). I CONTACTED THE ABBOTT REP TO TRY TO GAIN ACCESS TO MY IMPLANT. IT WAS UNSUCCESSFUL. MY IMPLANTED DEVICE WILL BE REMOVED ON (B)(6)2023 BY (B)(6). I HAVE NOT BEEN ABLE TO USE MY DEVICE SINCE (B)(6) 2022. CHRONIC PAIN. REFER TO ADDITIONAL DOCUMENTS IN I2K.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2200031 PROCLAIM NEUROSTIMULATION SPINAL STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ABBOTT MEDICAL

Patients

Seq Age Sex Outcome Treatment
1 58 YR Unknown Other