FDA.reportPublic FDA data

MAUDE MDR 6644211

MDR report key
6644211
Report number
1028232-2017-01962
Event key
0
Event type
3
Date of event
2016-11-18
Date received
2017-06-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
6024 JEAN ROAD LAKE OSWEGO OR 97035 US
Phone
877-877-8772
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REOCOR DEXTERNAL PACEMAKERBIOTRONIK SE & CO. KGOVJ365529SEE MODEL NO.R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-1501. D

Event Narratives#

N

Patient 1

THE BIOTRONIK REOCOR IS A BATTERY POWERED, EXTERNAL DUAL CHAMBER PACEMAKER, WHICH CAN BE USED IN CONJUNCTION WITH TEMPORARY PACEMAKER LEADS (INCLUDING ENDOCARDIAL LEADS AND TRANSVENOUS IMPLANTABLE CATHETERS) FOR TEMPORARY ATRIAL, VENTRICULAR AND AV SEQUENTIAL PACING IN CLINICAL SETTINGS. THE CONNECTION IS MADE DIRECTLY OR VIA A SEPARATE PATIENT CABLE AND ADAPTER, IF NECESSARY. BASED ON THE INFORMATION BIOTRONIK RECEIVED FROM (B)(6) ON 5TH MAY 2017, THE INCIDENT OCCURRED ON (B)(6) 2016. DESPITE SEVERAL ATTEMPTS TO RECEIVE THE DEVICE FOR ANALYSIS, NEITHER THE STIMULATION CABLES NOR THE REOCOR PACEMAKER WERE RETURNED FOR ANALYSIS. THEREFORE, THE BIOTRONIK INVESTIGATION IS BASED ON THE INFORMATION FROM THE MEDICAL PHYSICS INVESTIGATION REPORT PROVIDED BY THE HOSPITAL, AS WELL AS THE ADDITIONAL INFORMATION OBTAINED DURING A BIOTRONIK REPRESENTATIVE VISIT AT THE HOSPITAL ON 11TH MAY 2017. THE HOSPITAL MEDICAL PHYSICS INVESTIGATION REPORT STATED THAT THE DISCONNECTION OF ONE STIMULATION CABLE FROM THE REOCOR RESULTED IN THE INCIDENT. THE MEDICAL PHYSICS INVESTIGATION REPORT FURTHER DESCRIBED THAT THE STANDARD PROCEDURE AS FOLLOWED BY THE HOSPITAL STAFF WAS TO HANG UP THE REOCOR ON THE STIMULATION CABLES INSTEAD OF USING THE HANGER ON THE REVERSE SIDE OF THE DEVICE, OR ANY OTHER FIXATION TO RELIEF THE PULLING FORCES ON THE STIMULATION CABLES. ADDITIONALLY, NO CONTINUOUS MONITORING OF THE PATIENT WAS PERFORMED USING AN EXTERNAL ECG, WHILE THE PATIENT WAS DEPENDENT ON THE ANTI BRADYCARDIA PACING DELIVERED BY THE REOCOR. THESE OPERATING PROCEDURES WERE CONFIRMED DURING THE VISIT OF THE BIOTRONIK REPRESENTATIVE. THIS IS HOWEVER AGAINST THE INSTRUCTION FOR USE, WHICH EXPLICITLY SPECIFY TO OPERATE THE REOCOR PACEMAKER ONLY EITHER HORIZONTALLY ON A NON SLIP SURFACE OR AFFIXED TO THE PATIENT ARMBAND OR FROM A HANGING POSITION ON THE INFUSION STAND USING THE HANGER ON THE REVERSE SIDE OF THE DEVICE. THIS ENSURES SAFE OPERATION AS NO PULLING FORCES ARE EXERTED ON THE STIMULATION CABLES. ADDITIONALLY, THE INSTRUCTIONS FOR USE MANDATE THAT DURING USE OF A REOCOR PACEMAKER, THE HEART RATE OF THE PATIENT IS TO BE MONITORED WITH AN EXTERNAL ECG MONITOR WITH ALARM FUNCTION. IN CONCLUSION, THE HOSPITAL MEDICAL PHYSICS INVESTIGATION REPORT SUGGESTS PULLING FORCES HAVE CAUSED THE INCIDENT. THE INSTRUCTIONS FOR USE MANDATE ONLY A FORCE FREE CONNECTION OF THE STIMULATION CABLES.

D

Patient 1

OUS MDR - IT WAS REPORTED TO US THAT A PATIENT DEPENDENT ON TEMPORARY EPICARDIAL PACING WAS FOUND IN CARDIAC ARREST AT APPROXIMATELY 5:00 ON (B)(6) 2017. STATEMENTS FROM THE FIRST CLINICAL STAFF ON SCENE SUGGESTED THAT ONE PIN OF ONE OF THE TWO PACING EXTENSION CABLES APPEARED TO BE DISCONNECTED FROM THE TEMPORARY PACEMAKER WHEN THE PATIENT WAS FOUND, AND THE SUBSEQUENT LOSS OF PACING FUNCTION WAS CONSIDERED LIKELY TO HAVE BEEN THE CAUSE OF THE CARDIAC ARREST. NEITHER THE ORIGINAL REOCOR D NOR THE CABLES INVOLVED IN THE INCIDENT COULD BE IDENTIFIED. THEY WERE NOT RETURNED TO BIOTRONIK. THE MANUFACTURE DATE IS UNAVAILABLE BECAUSE THE SERIAL IS UNKNOWN.