MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-05-06 for LEAD ADAPTOR BIS/BIS-40 manufactured by Oscor Inc..
[144141385]
Our investigation is still in progress, follow up report will be submitted if we found any further additional information.
Patient Sequence No: 1, Text Type: N, H10
[144141386]
It was reported that, overnight adaptor was attached to the atrial lead. In morning there was impedance spike to 3000 ohms uni/bip, 625 ohms sensing, 1. 5mv threshold 1. 0v @ 0. 4ms and noise noted. Patient was admitted for lead revision surgery, undertook provocation maneuvers and appeared to be at site of adapter. Surgical revision was performed on the left sided pocket and the adapter for atrial lead was inspected the distal setscrew was loose, doctor retightened setscrew and provocation maneuvers were done with no notable noise on the channel after fixing the setscrew. No other additional information available and no other adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2019-00039 |
| MDR Report Key | 8582349 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2019-05-06 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-07-19 |
| Device Manufacturer Date | 2018-01-02 |
| Date Added to Maude | 2019-05-06 |
| 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 HABROR FL 34683 |
| Manufacturer Country | US |
| Manufacturer Postal | 34683 |
| Manufacturer Phone | 7279372511 |
| Manufacturer G1 | OSCOR INC. |
| Manufacturer Street | 3816 DESOTO BLVD |
| Manufacturer City | PALM HABROR 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 | 2019-05-06 |
| Model Number | BIS/BIS-40 |
| Catalog Number | BIS/BIS-40 |
| Lot Number | C4-13629 |
| 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 HABROR FL 34683 US 34683 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-06 |