SELOX ST 53 346366

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-03-08 for SELOX ST 53 346366 manufactured by Biotronik Se & Co Kg.

Event Text Entries

[1437716] Per rep, this lead was mal-positioned and one day post-implant, it was repositioned.
Patient Sequence No: 1, Text Type: D, B5


[8442558] The device was not returned for analysis. The analysis is therefore based on the inspection of the quality documents accompanying this particular device. The mfg process for this device was re-investigated. All production steps had been performed accordingly. There was no sign of any inconsistency during the mfg process, which might be related to the clinical observation. In summary, the device was not returned for analysis. The review of the quality documents confirmed a regular device mfg.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1028232-2010-00235
MDR Report Key1631005
Report Source07
Date Received2010-03-08
Date of Report2010-02-15
Date of Event2010-01-26
Date Mfgr Received2010-02-15
Device Manufacturer Date2009-09-21
Date Added to Maude2010-03-18
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 NameSELOX ST 53
Generic NamePACER LEAD
Product CodeJXK
Date Received2010-03-08
Model Number346366
Catalog Number346366
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOTRONIK SE & CO KG
Manufacturer AddressBERLIN GM


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2010-03-08

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