FDA Adverse Event Injury Summary report: N

PROSPERA

MDR report key: 24547057 · Received March 9, 2026

Report

Report Number
MW5184907
Event Type
Injury
Date Received
March 9, 2026
Report Date
March 4, 2026
Manufacturer
BIOTRONIK NRO, INC.
Product Code
LGW
UDI-DI
04035479170110
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

FAULTY REMOTE, FAULTY RECHARGER X 2, FAULTY LEADS. BENEFIT (B)(6) TRIAL PATIENT (B)(6) SUSTAINED MULTIPLE ELECTRIC SHOCKS, STATIC IMPLANT DEVICE SHOCKS, A RECORD OF CONVERSATIONS VIA EMAILS WITH (B)(4), PLUS THE IGNORANCE OF SUPERVISOR FAILURE TO RESPOND TO ALL ATTEMPTS AS PER ADVISED BY (B)(4). SPECIFICS IN FINE DETAILS WERE SUPPLIED TO BE REJECTED AS NON-SPECIFICS AS PER (B)(4) EMAIL RESPONSE. WAS SORT ON HOW NOT SO NOR ANY FURTHER COMS. COMPLAINT LODGED TO (B)(4) INDEPENDENT DIRECTOR LEGAL & COMPLIANCE. AUTHOR HAS FILED WITH TGA (VTHERAPEUTIC GOODS ADMINISTRATION) AND HCCC (HEALTH CARE COMPLAINTS COMMISSION) AUSTRALIA WHO IS SEEKING TO LINK THIS COMPLAINT TO ALL BODIES IN GERMANY, AUSTRALIA & AMERICA. I NOTE IN 2026 THE JUSTICE DEPT OF AMERICA FOUND BIOTRONIK OREGON, GUILTY AND CONVICTED OF FRAUD CRIMES. I WISH TO ATTENTION I HAVE EVIDENCE ROCK SOLID IN BLACK & WHITE OF SUCH FRAUD PERSISTENT AND VERY MUCH ACTIVE WHICH IN CONJUNCTIONS WITH THIS EMAIL AIM TO GLOBALLY ACT ON ANY & ALL CRIMINAL FRAUDS, MEDICAL BREACHES OF ALL CODES OF COUNTRY ASSOCIATED IN A GLOBAL RESEARCH SPINAL CORD STIMULATOR TRIAL. PLEASE NOTE AP DR (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
606994 PROSPERA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BIOTRONIK NRO, INC. 457849 04035479170110

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown