MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-27 for SYNCHROMED II 8637-20 manufactured by Medtronic Puerto Rico Operations Co..
[185299759]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185299760]
Information was received from a consumer regarding a patient receiving an unknown dose and concentration of morphine. On (b)(6) 2020 it was reported the patient's pain pump refill date was on (b)(6) 2020 and the patient started hearing the alarm from her pump on (b)(6) 2020. The patient started throwing up the night before. The patient remembered what withdrawal felt like because they had experienced before, many years earlier. At the time of the report, the pump was "beeping like crazy" and they were very sick. The patient stated they could barely see. The patient stated they were going through hell and their healthcare provider would no longer see them due to insurance reasons. The patient's primary care doctor sent a prescription in for anti-nausea medication, but the pharmacy was out stock, and their doctor was off on the day of the call. The patient was redirected to seek urgent medical attention if they felt it was appropriate. The patient confirmed they were hearing the single toned low reservoir alarm. Physician listings were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06287 |
| MDR Report Key | 9890618 |
| Report Source | CONSUMER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2016-06-30 |
| 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 |
| 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 | 2017-12-28 |
| 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 |