MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for LEAD MODEL 303 303-20 manufactured by Cyberonics - Houston.
[188031787]
It was reported that patient had high impedance after their initial implant. Setting adjustments were made to attempt to see change in impedance but high impedance remained. X-rays were performed for patient. Device history records were reviewed and the device passed all functional specifications and quality tests and were sterilized prior to distribution. X-rays were reviewed for the event reported high lead impedance. Ap and lateral x-rays of the neck were available that displayed complete view of the neck and partial of chest. Based on the images provided, the feedthrough wires appeared intact at the connector pins, and the generator was placed in the upper left chest, as expected. Due to the angle of the generator in the images provided. It could not be assessed if the lead pin was past the second connector block. The lead was observed in the patient? S neck and appeared to be routed toward the patient? S left chest. No strain relief bend or loop was present. One tie down was present but not placed per labeling. No obvious fractures or sharp angles were found in the portion of the image where the lead could be assessed. Note that a portion of the lead was routed behind the generator so it could not be assessed. Based on the images provided, the cause of the high impedance could not be determined. Note that incomplete pin insertion, lead fracture and the presence of micro-fractures could not be ruled out. No known surgery has occurred to date. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00502 |
| MDR Report Key | 9903225 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-29 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-12-03 |
| Date Added to Maude | 2020-03-31 |
| 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 | MRS. RACHEL KOHN |
| Manufacturer Street | 100 CYBERONICS BLVD SUITE 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal | 77058 |
| Manufacturer Phone | 2812287200 |
| Manufacturer G1 | CYBERONICS - HOUSTON |
| Manufacturer Street | 100 CYBERONICS BLVD SUITE 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77058 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD MODEL 303 |
| Generic Name | LEAD |
| Product Code | LYJ |
| Date Received | 2020-03-31 |
| Model Number | 303-20 |
| Lot Number | 205117 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERONICS - HOUSTON |
| Manufacturer Address | 100 CYBERONICS BLVD HOUSTON TX 77058 US 77058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |