MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for SYNCHROMED II 8637-20 manufactured by Medtronic Puerto Rico Operations Co..
[185970444]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185970445]
Information was received from a healthcare provider (hcp) regarding a patient who was receiving heparin with a concentration and dose of 1 ml/ml at 0. 7 units/day and floxuridine with a concentration and dose of 1 ml/ml at 1 ml/day via implantable drug delivery pump. It was reported that the patient had a hepatic artery infusion (hai) refill on (b)(6) 2020 and came back for another refill on (b)(6) 2020. When the hcp interrogated the pump it was showing the pump was in stopped pump mode and the tube set alarm occurred on (b)(6) 2020. They were unsure if the patient heard the pump alarming. They checked the pump logs and the logs showed the update on (b)(6) 2020 but there was not a successful update (pump restarted due to restart command). Discussed incomplete telemetry, interference, movement of tele head. Hcp stated that today ((b)(6) 2020) they were changing to heparinized saline. Discussed that the patient had not received the floxuridine post (b)(6) 2020 refill. Discussed contacting the physician to update them on the situation. Discussed contacting the local mdt rep for inservicing on programming and use of the programmer 8840. Discussed new tablet. No patient symptoms or further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06474 |
| MDR Report Key | 9908075 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-04-03 |
| 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 | 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 | 3 |
| Brand Name | SYNCHROMED II |
| Generic Name | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
| Product Code | LKK |
| Date Received | 2020-03-31 |
| Model Number | 8637-20 |
| Catalog Number | 8637-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-31 |