FDA.reportPublic FDA data

MAUDE MDR 3928570

MDR report key
3928570
Report number
2026095-2014-00080
Event key
0
Event type
3
Date of event
2014-05-11
Date received
2014-06-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MARIA WAGNER
Address
43 DISCOVERY, STE 100 IRVINE CA 92618 US
Phone
949-949-9499
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EZSTIM DUAL STIMULATOR/LOCATORSTIMULATOR, NERVE, PERIPHERALI-FLOW, LLC,KOIES4001032784000J2720066N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-090

Event Narratives#

D

Patient 1

FILL VOLUME: NA. FLOW RATE: NA. PROCEDURE: NA. CATHPLACE: NA. (NURSE (B)(6)): A CUSTOMER REPORTED THAT 3 PEOPLE GOT SHOCKED WHEN USING A STIMULATION, INCLUDING A PT AND 2 NURSES. PER HOSPITAL POLICY OF THE LOCATION WHERE PROBLEM OCCURRED, PT AND PROCEDURE RELATED INFO WILL NOT BE PROVIDED TO I-FLOW. REFERENCE: 22026095-2014-00079/(B)(4).

N

Patient 1

METHOD: THE DEVICE HISTORY RECORD (DHR) REVIEW FOR THE SUSPECT LOT IS CURRENTLY IN PROGRESS. THE SUSPECT PART HAS BEEN RETURNED AND UNDERGOING EVAL. RESULTS: THERE ARE NO RESULTS AVAILABLE AS THE INVESTIGATION AND EVAL IS CURRENTLY BEING CONDUCTED. CONCLUSIONS: THE DEVICE IS UNDERGOING AN EVAL BUT HAS NOT YET BEEN COMPLETED. AT THE TIME OF COMPLETION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.