MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-15 for ASCENDA 8780 manufactured by Medtronic Neuromodulation.
[127368768]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[127368769]
Information was received from a manufacturer representative regarding a catheter used with an implanted infusion system. No patient involvement was reported. It was reported that prior to opening the catheter peel pack, the representative noticed the sleeve of the collet was missing from that connector. The representative located it broken off in the peel pack. No environmental, external, or patient factors were thought to have led or contributed to the issue. The representative opened and used a new catheter issue, and the issue was not resolved. An image submitted with the report showed the collet sleeve separated from the catheter connector. No patient symptoms were reported and no further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-03336 |
| MDR Report Key | 8074460 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-15 |
| Date of Report | 2019-01-17 |
| Date of Event | 2018-11-14 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2017-02-10 |
| Date Added to Maude | 2018-11-15 |
| 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 | 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 | 2018-11-15 |
| Returned To Mfg | 2018-12-10 |
| Model Number | 8780 |
| Catalog Number | 8780 |
| Device Expiration Date | 2019-02-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-15 |