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Adverse Event Report

CARDIAC PACEMAKERS, POSSIS MEDICAL, INC. POSSIS MYOCARDIAL LEAD   back to search results
Model Number 1114
Event Date 03/20/1995
Patient Outcome  Required Intervention;
Event Description

Pt experiencing aicd shocks that are not preceded by palpitation or lightheadedness symptoms. Recent shocks shown to be due to oversensing. One shock documented recently during sinus rhythm. Portion of 2 leads removed and remainder capped.

 
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Brand NamePOSSIS MYOCARDIAL LEAD
Type of DeviceMYOCARDIAL LEAD
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CARDIAC PACEMAKERS, POSSIS MEDICAL, INC.
2905 northwest blvd
minneapolis MN 55441
Manufacturer (Section D)
CARDIAC PACEMAKERS, POSSIS MEDICAL, INC.
2905 northwest blvd
minneapolis MN 55441
Device Event Key26068
MDR Report Key25511
Event Key23742
Report Number25511
Device Sequence Number1
Product CodeLWS
Report Source User Facility
Reporter Occupation Lay User/Patient
Type of Report Initial
Report Date 03/23/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/1995
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL Number1114
OTHER Device ID NumberNI
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/20/1995
Device Age31 mo
Event Location Home
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 08/08/1995 Patient Sequence Number: 1
#TreatmentTreatment Date
1,VENTAK #1600 SERIAL #638001 POSSES LEAD 1114 SERIA,
2,01 POSSES LEAD 1114 SERIAL #019242,

Database last updated on January 30, 2009

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