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 2020-03-27 for SYNCHROMED II 8637-20 manufactured by Medtronic Puerto Rico Operations Co..
[185242531]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185242532]
Information was received from a manufacturing representative (rep) regarding a patient receiving 5 mg/ml of dilaudid at 0. 481 mg/day via an implantable pump. It was reported the patient was non-compliant and last had their pump refilled in (b)(6) 2019. The patient had missed multiple appointments since that time. The patient wanted to have their pump removed for an unknown reason. A couple days earlier, relative to (b)(6) 2020, the patient was seen in the clinic and wanted their pump refilled. However, the patient had taken some xanax and was reportedly "drugged out," so the healthcare provider did not refill the pump. It was reported the patient was currently in the hospital for unknown reasons. The pump status had not been checked. Troubleshooting considerations were reviewed and the rep was redirected to contact the managing healthcare provider. Additional information was received from the rep on 2020-03-25. It was reported that the patient missed? Multiple? Refill appointments. It was not thought that the pump went empty. No further action is planned until the patient is released from the hospital. The patient was not in the hospital due to the device/therapy, it was for type a flu. It was unknown how the patient was doing at this time. There were no further complications reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06273 |
| MDR Report Key | 9889074 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2015-05-11 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-27 |
| Model Number | 8637-20 |
| Catalog Number | 8637-20 |
| Device Expiration Date | 2016-10-28 |
| 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 | 2020-03-27 |