MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-19 for LEAD ADAPTOR BIS/BIS-40 manufactured by Oscor Inc.
[136605213]
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
[136605214]
It was reported that, implanting physician had to regain axillary venous access to place a lead 5076-85 ((b)(4)) which was then tunneled to the abdomen. Physician removed the already implanted 3830-59 because of both adaptors failed and lead could not be tunneled to the pocket and connected to an abdominal icd. This 3830 lead was then to be extended and tunneled to the abdomen where it was to be connected to an icd. Because of the adaptor issue physician choose to remove the 3830 lead and placed 5076-85 lead and tunnel to the abdominal pocket. On both adaptor the distal set screw could not be engaged with a wrench kit to tighten the screw. Physician had to cut silicone away to be able to engage the screw. Upon attempts to engage the screw, the screw would not lock down on the terminal pin of the lead - the screw spun incessantly. Eventually leading to stripping of the screw. At a couple moments the screw just fell out of the adapter port. Re-engaging the screw was challenging. First adaptor was connected to the device where electrically checked okay but then became very noisy. Physician try to attempt second adaptor. In second adapter, the lead the lead could not be inserted all the way into the housing port. Physician believes the original issue comes from the distal set screw not engaged in the port housing during manufacture. There was no patient complication reported. There was 15 minutes delay reported because of tinkering so the port could have been bent or lost it's form. No additional information is available. For first adaptor see mdr 1035166-2019-00009.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2019-00010 |
| MDR Report Key | 8351757 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-19 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-01-02 |
| Date Mfgr Received | 2019-04-29 |
| Device Manufacturer Date | 2017-03-02 |
| Date Added to Maude | 2019-02-19 |
| 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 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 | 2019-02-19 |
| Model Number | BIS/BIS-40 |
| Catalog Number | BIS/BIS-40 |
| Lot Number | C4-13270 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 346831816 US 346831816 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-19 |