FDA.reportPublic FDA data

MAUDE MDR 2860311

MDR report key
2860311
Report number
1028232-2012-02931
Event key
0
Event type
3
Date of event
2012-10-18
Date received
2012-11-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1SETROX S 53PACER LEADBIOTRONIK SE & CO. KGNVZ350974SEE MODEL NO.Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-11-2101. O

Event Narratives#

D

Patient 1

THIS SYSTEM WAS EXPLANTED ON (B)(6) 2012 BECAUSE THE PATIENT CHOSE TO HAVE IT REMOVED. THE PATIENT DID NOT WANT THE DEVICE ANYMORE. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. THERE ARE NO KNOWN ADVERSE EVENTS REPORTED FOR THIS PATIENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

N

Patient 1

THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL ANALYSIS. THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. MERELY SLIGHT SIGNS OF ABRASION WERE FOUND ALONG THE LEAD BODY. THE CUTTINGS OF THE INSULATION RESULTED MOST LIKELY FROM THE EXPLANTATION PROCEDURE. DURING THIS ANALYSIS, NO FURTHER DEVIATIONS WERE NOTED. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.