MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-02 for LEAD ADAPTOR BLV/BIS-4403 manufactured by Oscor Inc..
[174534679]
Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[174534680]
It was reported per call from the field representative, that system was infected and entire system was removed (laser extracted) today. Unclear if patient on iv antibiotics. Device will be returned. Leads were used for cultures. Very clearly infected. Additional information requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2020-00001 |
| MDR Report Key | 9540867 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-02 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-10-22 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2017-05-02 |
| Date Added to Maude | 2020-01-02 |
| 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 | 3 |
| Manufacturer Contact | MR. DOUG MYERS |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 34683 |
| Manufacturer Country | US |
| Manufacturer Postal | 34683 |
| Manufacturer Phone | 7279372511 |
| Manufacturer G1 | OSCOR INC. |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 34683 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34683 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD ADAPTOR |
| Generic Name | PACEMAKER LEAD ADAPTOR |
| Product Code | DTD |
| Date Received | 2020-01-02 |
| Model Number | BLV/BIS-4403 |
| Catalog Number | BLV/BIS-4403 |
| Lot Number | C4-13345 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC. |
| Manufacturer Address | 3816 DESOTO BLVD. PALM HARBOR FL 34683 US 34683 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-02 |