MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-11-14 for VENTAK PRIZM AVT 1900 NA manufactured by Cardiac Pacemakers, Inc.
[419443]
Event description guidant received information that this implantable cardioverter defibrillator (icd) reached elective replacement indicator (eri) and was explanted after approximately 2 years of service. The device will be returned to guidant where it will be analyzed for premature battery depletion.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2124215-2005-11181 |
MDR Report Key | 659324 |
Report Source | 05 |
Date Received | 2005-11-14 |
Date of Report | 2005-08-22 |
Date of Event | 2005-08-22 |
Date Reported to Mfgr | 2005-08-22 |
Date Mfgr Received | 2005-08-22 |
Device Manufacturer Date | 2001-08-02 |
Date Added to Maude | 2006-01-05 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VENTAK PRIZM AVT |
Generic Name | IMPLANTABLE PULSE GENERATOR |
Product Code | MPC |
Date Received | 2005-11-14 |
Model Number | 1900 |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Device Expiration Date | 2002-08-02 |
Operator | UNKNOWN |
Device Availability | N |
Device Age | 3 YR |
Device Eval'ed by Mfgr | R |
Implant Flag | Y |
Date Removed | V |
Device Sequence No | 1 |
Device Event Key | 648763 |
Manufacturer | CARDIAC PACEMAKERS, INC |
Manufacturer Address | GUIDANT CORPORATION 4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112UNK US NA |
Baseline Brand Name | PRIZM AVT |
Baseline Generic Name | IMPLANTABLE ATRIAL GENERATOR |
Baseline Model No | 1900 |
Baseline Catalog No | NA |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2005-11-14 |