FDA.reportPublic FDA data

MAUDE MDR 3960463

MDR report key
3960463
Report number
2026095-2014-00079
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
45 DISCOVERY, SUITE 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
1EZSTM DUAL STIMULATOR/LOCATORSTIMULATOR, NERVE, PERIPHERALI-FLOW CORP.KOIES4001032784000J2720066N Y

Patients#

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

Event Narratives#

D

Patient 1

FILL VOLUME: N/A; FLOW RATE: N/A; PROCEDURE: N/A; CATHPLACE: N/A. (PATIENT). A CUSTOMER REPORTED THAT 3 PEOPLE GOT SHOCKED WHEN USING A STIMULATOR, INCLUDING A PATIENT AND 2 NURSES. PER HOSPITAL POLICY OF THE LOCATION WHERE PROBLEM OCCURRED, PATIENT AND PROCEDURE RELATED INFORMATION WILL NOT BE PROVIDED TO I-FLOW. REFERENCE: 22026095-2014-00080/(B)(4), 202695-2014-00081/(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 EVALUATION. RESULTS: THERE ARE NO RESULTS AVAILABLE AS THE INVESTIGATION AND EVALUATION IS CURRENTLY BEING CONDUCTED. CONCLUSIONS: THE DEVICE IS UNDERGOING AN EVALUATION BUT HAS NOT YET BEEN COMPLETED. AT THE TIME OF COMPLETION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.