FDA.reportPublic FDA data

MAUDE MDR 2639694

MDR report key
2639694
Report number
1028232-2012-01639
Event key
0
Event type
3
Date of event
2012-05-21
Date received
2012-06-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

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
1LINOX SMART S 65ICD LEADBIOTRONIK SE & CO. KGLWS369818SEE MODEL NO.Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-06-2501. H

Event Narratives#

N

Patient 1

THE LEAD ARRIVED DESTROYED. IT HAD BEEN SEVERED 13.5 CM DISTAL FROM THE IS-1 CONNECTOR PIN. EIGHT CM OF THE LEAD BODY ARE MISSING BETWEEN THE PROXIMAL AND DISTAL LEAD FRAGMENT . THE ANALYSIS OF THE RETURNED LEAD FRAGMENTS REVEALED A CONDUCTOR FRACTURE IN THE ROPE CONDUCTOR TO THE RV SHOCK COIL PROXIMALLY. WITH HIGH PROBABILITY, THIS DAMAGE IS THE RESULT OF INTENSE TENSILE STRENGTHS DURING THE EXPLANTATION PROCEDURE AND THE REASON FOR THE SHOCK IMPEDANCE OF < 150 OHM. ADDITIONAL DAMAGES ARE THE RESULT OF THE EXPLANTATION PROCEDURE. THE ANALYSIS OF THE LEAD FRAGMENTS DID NOT REVEAL DAMAGES THAT COULD BE LINKED TO THE UNFAVORABLE TELEMETRY MEASUREMENTS AND THE SENSING OF ARTEFACTS. THERE WAS NO INDICATION FOR MATERIAL OR PRODUCTION ERRORS.

D

Patient 1

OUR MDR - POOR TELEMETRY VALUES WERE NOTED ALONG WITH ARTIFACT SENSING. BEFORE THE REVISION, THE SHOCK IMPEDANCE WAS IN AN ADEQUATE RANGE. IT WAS NOTED THAT THE SCREW CONNECTIONS IN THE HEADER WERE NOT CORRECTLY TIGHTENED, SO THIS WAS CORRECTED. SEVERAL MEASUREMENTS OF THE SHOCK IMPEDANCE WERE TAKEN AND ALL WERE > 150 OHM FOR NO APPARENT REASON. ALL SCREW CONNECTIONS WERE CHECKED, ALL CONNECTIONS WERE DISCONNECTED AND RECONNECTED, AND THE POCKET WAS RINSED. WHEN ALL ATTEMPTS WERE UNSUCCESSFUL, THE LEAD WAS EXPLANTED AND EXCHANGED FOR A NEW ONE. NO MICROSCOPIC DAMAGE COULD BE FOUND WITH THE LEAD.

N

Patient 1

OUS MDR.