MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for SYNCHROMED II 863740 manufactured by Mdt Puerto Rico Operations Co.
[185613351]
(b)(6). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185613352]
Information was received from a consumer regarding a patient receiving morphine at 30 mg/day via an implanted pump. On (b)(6) 2020 the patient reported that once before maybe 10 years ago or longer he had gone to the er (emergency room) because he had gone in for a refill and they put something in the pump and by the next day he was sick and sneezing and sick to his stomach. After another day or so, he was sicker and could hardly breath. He was then in a navy hospital 3 days trying to get better. It was a whole week. He was sent for tests, maybe an mri, and they showed the pump was working fine. He was also on oral medications. They found out what was put in the pump was not supposed to be in there. Per the patient, he was never told if the medication or dosage/concentration was incorrect. He stated that he seemed to be going through withdrawal. Nine hours after they refilled it, he was much better. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06354 |
| MDR Report Key | 9897239 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2007-01-20 |
| 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 | 863740 |
| Catalog Number | 863740 |
| Device Expiration Date | 2008-07-14 |
| 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. Hospitalization | 2020-03-30 |