FDA.reportPublic FDA data

MAUDE MDR 3731919

MDR report key
3731919
Report number
1226420-2014-00030
Event key
0
Event type
3
Date of event
2014-03-11
Date received
2014-04-07
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#

Contact
KAYLEE BOISVERT
Address
180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US
Phone
603-603-6038
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GENERATOR PULSAR II REFURBGENERATOR,ELECTROSURGICAL,COAGULATION,CANCERMEDTRONIC ADVANCED ENERGY, LLCMULPS100-102RFPS100-102RFN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-04-070

Event Narratives#

D

Patient 1

DURING PACEMAKER GENERATOR EXCHANGE PROCEDURE, IN WHICH THE PULSAR SYSTEM WAS UTILIZED, IT WAS NOTICED THAT THE LEADS HAD TWO BROWN SPOTS ON THE LEAD INSULATION AND IT WAS FURTHER NOTICED THAT THE LEAD WAS DAMAGED AT THE TOP NEAR THE CAN (ON THE OUTSIDE OF THE INSULATION). SURGEON REPAIRED LEADS WITH NO PATIENT INJURY.

N

Patient 1

(B)(4). METHOD/RESULTS/CONCLUSION: GENERATOR STILL IN USE AND FACILITY NOT RETURNING FOR INVESTIGATION. (B)(4).

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.