MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-03-16 for LABSYSTEM STAMP AMPLIFIER 200915 manufactured by C.r. Bard, Inc. (bep).
[402336]
The physician called with a stim problem when he paces the his rva on stim channel on it also paces his hra on stim channel two. Pt went into tachycardia, physician was able to bring the pt back to normal sinus rhythm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222791-2005-00005 |
| MDR Report Key | 582202 |
| Report Source | 06 |
| Date Received | 2005-03-16 |
| Date of Report | 2005-02-15 |
| Date of Event | 2005-02-15 |
| Date Mfgr Received | 2005-02-15 |
| Date Added to Maude | 2005-03-18 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ELAINE REDMAN |
| Manufacturer Street | 55 TECHNOLOGY DR |
| Manufacturer City | LOWELL MA 01851 |
| Manufacturer Country | US |
| Manufacturer Postal | 01851 |
| Manufacturer Phone | 9784416202 |
| Manufacturer G1 | C.R. BARD, INC. (BEP) |
| Manufacturer Street | 55 TECHNOLOGY DR |
| Manufacturer City | LOWELL MA 01851 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01851 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LABSYSTEM STAMP AMPLIFIER |
| Generic Name | BASIC STAMP AMPLIFIER |
| Product Code | DRQ |
| Date Received | 2005-03-16 |
| Model Number | NA |
| Catalog Number | 200915 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 572045 |
| Manufacturer | C.R. BARD, INC. (BEP) |
| Manufacturer Address | * LOWELL MA * US |
| Baseline Brand Name | 200915-STAMP PLATFORM/115V |
| Baseline Catalog No | 200915 |
| Baseline Device Family | 126010065-LABSYSTEMS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K913875 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2005-03-16 |