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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK, GMBHTIR 60 UPLEAD, PACEMAKER

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BIOTRONIK, GMBH TIR 60 UP LEAD, PACEMAKER   Back to Search Results
Model Number TIR 60 UP
Event Date 08/26/1997
Event Type  Other   Patient Outcome  Other
Event Description

Intra-operatively the lead did not capture the myocardium, although the lead had appropriate sensing.

 
Manufacturer Narrative

The performed visual examination of the pacemaker electrode showed no damage to the electrical current pathways or the insulation material. The measurement of the complex impedance which allows an evaluation of the electrode tip's fractal coating resulted in values conforming with the specifications. The electrode is not defective.

 
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Brand NameTIR 60 UP
Type of DeviceLEAD, PACEMAKER
Baseline Brand NameTIR 60 UP
Baseline Generic NameLEAD, PACEMAKER
Baseline Catalogue NumberNA
Baseline Model NumberTIR 60 UP
Manufacturer (Section F)
BIOTRONIK, GMBH
woermannkehre
berlin
GERMANY 1D-12359
Manufacturer (Section D)
BIOTRONIK, GMBH
woermannkehre
berlin
GERMANY 1D-12359
Device Event Key123550
MDR Report Key126226
Event Key118698
Report Number1028232-1997-00061
Device Sequence Number1
Product CodeDTB
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation UNKNOWN
Type of Report Initial,Followup
Report Date 10/07/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberTIR 60 UP
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/08/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
UNK
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