MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-22 for ASCENDA 8784 manufactured by Medtronic Puerto Rico Operations Co..
[137310472]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[137310473]
Information was received from a healthcare provider (hcp) via a manufacturer representative on (b)(6) 2019 regarding a patient receiving gablofen (500mcg/ml at 50mcg/day) via an implanted infusion pump. The indication for use was intractable spasticity. The patient's medical history included severe spasticity. It was reported that the attached collets on the catheter included in the kit detached from the connector when the surgeon was handling it. The surgeon was trying to connect the pump segment to the spinal segment at the spine incision and the collets fell off. The patient was not experiencing any issues because of this. No diagnostics or troubleshooting were performed and there were no environmental, external, or patient factors that may have led or contributed to the issue. A new kit was opened and the connector was replaced during the implant procedure with a new one. The issue was resolved at the time of report and the patient's status was alive - no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2019-03806 |
| MDR Report Key | 8362673 |
| Date Received | 2019-02-22 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2018-12-20 |
| Date Added to Maude | 2019-02-22 |
| 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 PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ASCENDA |
| Generic Name | CATHETER, INFUSION |
| Product Code | JCY |
| Date Received | 2019-02-22 |
| Returned To Mfg | 2019-03-07 |
| Model Number | 8784 |
| Catalog Number | 8784 |
| 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 PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-22 |