KENTROX SL 65/16 STEROID 347351

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-11-12 for KENTROX SL 65/16 STEROID 347351 manufactured by Biotronik Se & Co. Kg.

Event Text Entries

[1649687] This system was explanted due to inappropriate shocks. No adverse pt side effects have been reported. The date of implant was not provided.
Patient Sequence No: 1, Text Type: D, B5


[8977628] Upon receipt, the lead was found dissected some 19 cm distal to the is-1 connector pin. Only the proximal part of the lead was received. It is reasonable to assume that the lead was dissected in the course of the surgery. Due to the damages the electrical inspection of the lead was limited to the dc resistances of the lead fragment. No peculiarities were found. The analysis did not reveal any sign of a material or manufacturing problem.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1028232-2010-02364
MDR Report Key1902816
Report Source01,07
Date Received2010-11-12
Date of Report2010-10-20
Date of Event2010-06-23
Date Mfgr Received2010-10-20
Device Manufacturer Date2006-08-28
Date Added to Maude2010-12-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street6024 JEAN ROAD
Manufacturer CityLAKE OSWEGO OR 97035
Manufacturer CountryUS
Manufacturer Postal97035
Manufacturer Phone8005470394
Manufacturer G1BIOTRONIK SE & CO. KG
Manufacturer CityBERLIN
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKENTROX SL 65/16 STEROID
Generic NameICD LEAD
Product CodeDTA
Date Received2010-11-12
Model Number347351
Catalog Number347351
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOTRONIK SE & CO. KG
Manufacturer AddressBERLIN GM


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2010-11-12

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