MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-31 for ASCENDA 8780 manufactured by Medtronic Neuromodulation.
[109666508]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[109666509]
Information was received from a healthcare professional (hcp) regarding a catheter used with an implanted infusion pump. Per the hcp, the catheter was not used as it broke during the procedure and it was discarded in the or (operating room). The hcp could not remember the date of the event or many details, but noted that they didn't think there was a defect with the catheter. The hcp thought it was the patient's anatomy as the patient was a child. The manufacturer representative present at the case further noted that the physician damaged both catheters by bending them before implanting them in the patient. The account reportedly felt it was user error so the catheter was not returned. The device was never implanted, so no additional tunneling was required. There was no impact to the patient and the device wasn't used further. It was specified that the implant was successful. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-01643 |
| MDR Report Key | 7557247 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2018-03-20 |
| Date Added to Maude | 2018-05-31 |
| 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 | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCENDA |
| Generic Name | CATHETER, INFUSION |
| Product Code | JCY |
| Date Received | 2018-05-31 |
| Model Number | 8780 |
| Catalog Number | 8780 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-31 |