MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-01-31 for NBIH? TEMPORARY PACING ELECTRODE CATHETER 007153P manufactured by C.r. Bard, Inc. (covington) -1018233.
[183167696]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183167697]
It was reported that the bipolar pacing electrode catheter would not power up, and the hose was changed but the device still did not work. Another probe was used on the patient to complete the procedure but the procedure was delayed and the patient was in a delicate state. Per additional information from the ibc via email 09jan2020, the device would not produce an electrical current or pace. The patient did not require additional sedatives or medication to maintain cardiac output while the electrodes were switched out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00684 |
| MDR Report Key | 9653526 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-01-31 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-11-19 |
| Date Added to Maude | 2020-01-31 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NBIH? TEMPORARY PACING ELECTRODE CATHETER |
| Generic Name | BIPOLAR PACING ELECTRODE CATHETER |
| Product Code | LDF |
| Date Received | 2020-01-31 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 007153P |
| Catalog Number | 007153P |
| Lot Number | GFDW1815 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |