FDA Adverse Event Injury Summary report: N

EXTRACORPREAL SHOCK WAVE DEVICE

MDR report key: 21297982 · Received January 31, 2025

Report

Report Number
MW5165583
Event Type
Injury
Date Received
January 31, 2025
Date of Event
November 16, 2023
Report Date
January 29, 2025
Manufacturer
STORZ MEDICAL AG
Product Code
NBN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

PATIENT WITH A HISTORY OF LUMBAR DEGENERATIVE DISC DISEASE AND RIGHT L5 (ANTERIOR LE (LEFT EXTREMITY)) RADICULAR PAIN HAD INCREASED PAIN INTENSITY, NEW BILATERAL CONSTANT HIGH-INTENSITY PAIN (R>L (RIGHT GREATER THAN LEFT)) IN MEDIAL BUTTOCK REGION AND NEW BILATERAL 5TH LE DIGIT NUMBNESS ONE DAY POST EPAT (EXTRACORPOREAL PULSE ACTIVATION TECHNOLOGY) THERAPY (PERFORMED BY PT (PHYSICAL THERAPIST)) TO BILATERAL PIRIFORMIS MUSCLES. OVER THE COURSE OF APPROXIMATELY 4 MONTHS, THE LEFT-SIDED PAIN RESOLVED, HOWEVER, THE BILAT 5TH DIGIT NUMBNESS AND CONSTANT PAIN (AREA MEDIAL TO R ISCHIAL TUBEROSITY) REMAINS, THOUGH AT A DECREASED INTENSITY FROM THE TREATMENT DATE. MRI (MAGNETIC RESONANCE IMAGING) OF SPINE ((B)(6) 2023) SHOWED SEVERE DISC SPACE NARROWING AT L5-S1, AND L4-L5 AND L5-S1 SMALL DIFFUSE DISC BULGE AND R MILD-MOD AND L MILD NEURAL FORAMINAL NARROWING. PELVIC MRI ((B)(6) 2023) WITH NO ABNORMAL MASS OR EDEMA ALONG PATH OF BILATERAL LUMOSCAL PLEXUS THROUGH GREATER SCIATIC FORAMEN. TREATMENT INCLUDED 2 6-DAY TAPERS OF ORAL STEROIDS (WITH RELIEF ON DAY 2-3; PAIN RETURNED THEREAFTER). TWO EPIDURAL STEROID INJECTIONS ((B)(6) 2023; BILAT S1 FOLLOWED BY R L5 AND R S1) DID NOT BRING RELIEF. CURRENTLY ON 1200 MG GBP (GABAPENTIN) WITH CONTINUED PAIN (LEVEL - 5-6 EVERY DAY). PER PT, EPAT MACHINE WAS STORZ WITH CERAMIC TIP USED AT 3.5 BAR, 3000 PULSES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1245131 EXTRACORPREAL SHOCK WAVE DEVICE GENERATOR, SHOCK-WAVE, FOR PAIN RELIEF NBN STORZ MEDICAL AG

Patients

Seq Age Sex Outcome Treatment
1 62 YR Female Other GBP (GABAPENTIN).| NEURIVE VITAMIN SUPPLEMENT.| VAGIFEM.