MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-01 for TEMPO TEMPORARY PACING LEAD T1106 manufactured by Biotrace Medical, Inc..
| Report Number | 3013472601-2019-00005 |
| MDR Report Key | 9267971 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-01 |
| Date of Report | 2019-10-28 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-10-03 |
| Device Manufacturer Date | 2019-08-22 |
| Date Added to Maude | 2019-11-01 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEN XAVIER |
| Manufacturer Street | 3925 BOHANNON DRIVE SUITE #200 |
| Manufacturer City | MENLO PARK 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6507794999 |
| Manufacturer G1 | BIOTRACE MEDICAL, INC. |
| Manufacturer Street | 3925 BOHANNON DR. SUITE #200 |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMPO TEMPORARY PACING LEAD |
| Generic Name | TEMPORARY PACING LEAD |
| Product Code | LDF |
| Date Received | 2019-11-01 |
| Returned To Mfg | 2019-10-21 |
| Model Number | T1106 |
| Catalog Number | T1106 |
| Lot Number | 31140 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRACE MEDICAL, INC. |
| Manufacturer Address | 3925 BOHANNON DR. SUITE #200 MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-01 |