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.
[419522]
Event description guidant received information that this implantable cardioverter defibrillator (icd), implanted for 37. 6 months, was explanted due to the elective replacement indicator (eri). The physician expressed dissatisfaction with regard to device longevity. Another guidant icd was subsequently implanted. The device was returned to guidant for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2005-11201 |
| MDR Report Key | 659318 |
| Report Source | 05 |
| Date Received | 2005-11-14 |
| Date of Report | 2005-08-25 |
| Date of Event | 2005-08-25 |
| Date Reported to Mfgr | 2005-08-25 |
| Date Mfgr Received | 2005-08-25 |
| Device Manufacturer Date | 2001-07-11 |
| 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 |
| Returned To Mfg | 2005-09-13 |
| Model Number | 1900 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2002-07-11 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 648757 |
| 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 |