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 2020-03-30 for SYNCHROMED II 8637-40 manufactured by Mdt Puerto Rico Operations Co.
[186570547]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186570548]
Information was received from a healthcare provider via a company representative regarding a patient receiving an unknown drug via an implantable pump. On (b)(6) 2020 it was reported that in the last two refills, the patient's pump had an expected volume of 6ml and there was 11ml in the pump. There were no reported environmental, external or patient factors that may have led or contributed to the issue. The diagnostics and troubleshooting performed was they refilled the pump. The actions and interventions taken to resolve the issue was a pump replacement was planned. Surgical intervention did not occur but was planned and scheduled for (b)(6) 2020. The patient status was noted as alive, no injury and no further complications were reported regarding the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06386 |
| MDR Report Key | 9898118 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2014-01-14 |
| Date Added to Maude | 2020-03-30 |
| 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 | MDT PUERTO RICO OPERATIONS CO |
| Manufacturer Street | RD 31 KM 24 HM 4 |
| 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 | 2020-03-30 |
| Model Number | 8637-40 |
| Catalog Number | 8637-40 |
| Device Expiration Date | 2015-07-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT PUERTO RICO OPERATIONS CO |
| Manufacturer Address | RD 31 KM 24 HM 4 JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |