FDA.reportPublic FDA data

MAUDE MDR 9908214

MDR report key
9908214
Report number
3004593495-2020-00368
Event key
0
Event type
3
Date of event
2020-03-18
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PAULA BIXBY
Address
8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DUAL CHAMBER TEMPORARY PACEMAKERPULSE-GENERATOR, PACEMAKER, EXTERNALPLEXUS MANUFACTURING SDN. BHDDTE53925392Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

PRODUCT ANALYSIS: ANALYSIS WAS ABLE TO CONFIRM THAT AN ERROR CODE WAS ENCOUNTERED ON THE EXTERNAL PULSE GENERATOR (EPG). ANALYSIS ALSO NOTED THAT THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS CONTAMINATED AND FAILED THE INCOMING FUNCTIONAL VENTRICULAR PACE PULSE NOISE TEST, THE HANGER ASSEMBLY WAS BROKEN, THE UPPER CASE WAS CONTAMINATED, THE KEYPAD WAS CONTAMINATED, THE LOWER CASE WAS BROKEN, THE MAIN SEAL WAS CONTAMINATED, THE DISPLAY WAS CONTAMINATED, THE DISPLAY FRAME AND TWO DISPLAY GROMMETS WERE CONTAMINATED, TWO CASE SCREWS WERE CONTAMINATED, TWO MAIN PCB SCREWS WERE CONTAMINATED, AND MULTIPLE ERRORS WERE FOUND IN THE LOGS. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE DEVICE PASSED ALL FINAL FUNCTIONAL TESTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT AN ERROR CODE WAS ENCOUNTERED ON THE EXTERNAL PULSE GENERATOR (EPG). THE EPG WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE EPG SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.