FDA.reportPublic FDA data

MAUDE MDR 9744387

MDR report key
9744387
Report number
9744387
Event key
0
Event type
3
Date of event
2020-02-17
Date received
2020-02-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NAPACEMAKER LEAD ADAPTORMEDTRONIC, INC.DTD518932* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2401. O

Event Narratives#

D

Patient 1

FROM STAFF: PATIENT HAS A TEMP WIRE. PACER WAS HUNG ON IV POLE. WAS TURNING PATIENT AND PACER HOLDER RIPPED AWAY. PACER FELL ON PATIENTS' HEAD. PATIENT HAS A SMALL HEMATOMA AS WELL. PATIENT STATED THAT WHEN WAS TURNED ONTO RIGHT SIDE TO BE REPOSITIONED ARM GOT CAUGHT ON THE CABLE FROM THE PACER WIRE TO THE GENERATOR AND IT PULLED THE BAG OFF THE POLE RESULTING IN BEING HIT ON LEFT SIDE OF FOREHEAD. PATIENT SAID IT INITIALLY WAS SORE BUT NOW HAS NO FEELING OF PAIN IN THAT AREA. A SMALL HEMATOMA WAS INITIALLY REPORTED BUT COULD ONLY SEE A VERY SMALL (5 MM ROUND) FLAT PINK SPOT. PACER GENERATOR WAS HUNG IN APPROVED BAG AT THE TIME BUT SHOULD NOT HAVE BEEN UP SO HIGH ON IV POLE. PACER IS NOW HUNG IN APPROVED BAG ON BUILT IN IV POLE AT HEAD OF BED WITH ADEQUATE CABLE SECUREMENT.