MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-05-12 for 2001145-MMJB STIM MODULE CABLE * manufactured by C.r. Bard, Inc..
[375144]
It has been reported to co that the "stim 1 & 2 out" connector plug on the cable which is associated with the multi module junction box, was incorrectly plugged into the "trigger in" input on stamp amplifer. It was also reported that when a stimulator signal was applied to the channel 1 input, the signal was observed at the stim 1 channel pacing site and unexpectedly at the stim 2 channel pacing site. The complaint is under investigation and there was no report of pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222791-2004-00003 |
| MDR Report Key | 562426 |
| Report Source | 06 |
| Date Received | 2004-05-12 |
| Date of Report | 2004-04-29 |
| Date of Event | 2004-04-28 |
| Date Mfgr Received | 2004-04-29 |
| Date Added to Maude | 2005-01-03 |
| 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 DRIVE |
| 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 DRIVE |
| 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 | 2001145-MMJB STIM MODULE CABLE |
| Generic Name | * |
| Product Code | DRQ |
| Date Received | 2004-05-12 |
| Model Number | * |
| Catalog Number | 2001145 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 527126 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 55 TECHNOLOGY DR. LOWELL MA 01851 US |
| Baseline Brand Name | 2001145-MULTI-MODULE JUNC BOX STIM MODULE |
| Baseline Generic Name | 067 |
| Baseline Catalog No | 2001145 |
| Baseline Device Family | 126020067-LABSYSTEM ACCESSORIES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K883152 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-12 |