MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-11-14 for VENTAK PRIZM AVT 1900 NA manufactured by Cardiac Pacemakers, Inc.
[419518]
Event description guidant received information that implantable cardioverter defibrillator (icd) was reprogrammed in july according to the guidelines given on first advisory notice. An attempt was made to reprogram the device according the revised guidelines, however the device was unable to be interrogated. The device is scheduled for explant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2005-11231 |
| MDR Report Key | 659296 |
| Report Source | 07 |
| Date Received | 2005-11-14 |
| Date of Report | 2005-09-06 |
| Date of Event | 2005-09-06 |
| Date Reported to Mfgr | 2005-09-06 |
| Date Mfgr Received | 2005-09-06 |
| Device Manufacturer Date | 2002-02-05 |
| 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 | 2005-11-08 |
| Model Number | 1900 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2003-02-05 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 648735 |
| Manufacturer | CARDIAC PACEMAKERS, INC |
| Manufacturer Address | GUIDANT IRELAND CASHEL RD. CLONMEL, TIPPERARY IRELAND UNK UK UNK |
| 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 |