MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-15 for PACING LEAD ADAPTORS,SPLICERS AND EXTENSIONS 4403 manufactured by Oscor Inc..
[138924638]
The device was in use for treatment. The lead was not returned for analysis. As a result, the allegations against the lead cannot be confirmed. The device was in service for approximately 9 years, 6 months before being explanted on (b)(6) 2019. The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections. Quality assurance procedure blv/bis, 4403 lead adaptor in-process & final inspection: all finished adaptors and extensions will be inspected (100%). All products must meet pre-determined specifications in each step of this procedure. If product does not comply with specifications, it must be rejected. Inspection of product has to be performed under 10x magnification and laser weld under 30x magnification. Verify that there are eight crimp indentations on the proximal coil cavity of metal inner part #2-56 to hold the inner coil to the inner part. Verify that the coil filars are welded to the hull and the hull is welded to the bal seal with a minimum of 3 spots on the sides of the hull/bal seal. Verify that the coil filars are welded evenly all around the shaft of the inner part. Ensure that there is no weld residue. Weld should be smooth and shiny. Device is test for length, pull test, withdraw force, dimension, hipot test, resistance and cosmetic inspection. As per, instructions for use (ifu) possible complications infection. As with the introduction of any foreign object into the body, an infection might result. Removal of the device may be required. The adaptors are implanted in the extremely hostile environment of the human body. Because the adaptors are very small in diameter and must be very flexible, it inevitably reduces their potential performance and longevity. Adaptors may fail to function for a variety of causes, including medical complications, body rejection phenomenon, allergic reaction, fibrotic tissue problem, or a failure of adaptor by damage, fracture, or by breach of their insulation. Despite of all due care in design, component quality, manufacture and testing prior to sale, adaptors may be damaged by improper handling, use, placement or other intervening facts. Our lead did not fail to meet its performance specifications or cause or contribute to the infection. Infection is a recognized clinical event referenced in the device's labeling and/or reported in the medical literature. Based on the investigation, a capa is not required. These leads are no longer manufactured by oscor. Oscor will continue to monitor this event type. The event will be re-evaluated if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[138924639]
It was reported that system was explanted because of infection. Temp wire was used. No other adverse event was reported and no additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2019-00025 |
| MDR Report Key | 8424656 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-15 |
| Date of Report | 2019-07-26 |
| Date of Event | 2019-01-24 |
| Date Mfgr Received | 2019-07-26 |
| Device Manufacturer Date | 2008-11-21 |
| Date Added to Maude | 2019-03-15 |
| 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 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 346831816 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PACING LEAD ADAPTORS,SPLICERS AND EXTENSIONS |
| Generic Name | PACEMAKER LEAD ADAPTOR |
| Product Code | DTD |
| Date Received | 2019-03-15 |
| Model Number | 4403 |
| Catalog Number | 4403 |
| Lot Number | C2-10257 |
| Device Expiration Date | 2011-11-01 |
| 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 HABROR FL 34683 US 34683 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-15 |