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 8637-40 manufactured by Medtronic Puerto Rico Operations Co..
[186160681]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186160682]
Information was received from a consumer regarding a patient receiving morphine and fentanyl dose and concentration not reported via an implantable pump. The patient? S medical history included hard of hearing. On (b)(6) 2020 it was reported that the patient? S pump? Failed? And the patient had been in the hospital for 3 days now. The reporter stated that the pump needed to be replaced. Per the reporter in the early morning of (b)(6) 2020 they heard the pump critical alarm. The patient went into withdrawal a few hours later and then went to the er (emergency room). Per the reporter, the patient was originally at a va hospital but was now at a different hospital and was requesting a company representative to contact the physician. No further complications were reported regarding the event.
Patient Sequence No: 1, Text Type: D, B5
[186634308]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186634309]
On (b)(6) 26 2020 the healthcare provider requested to have a company representative come and interrogate the pump. The healthcare provider was redirected to the national answering service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06240 |
| MDR Report Key | 9887640 |
| Report Source | CONSUMER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2014-05-19 |
| 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 | 8637-40 |
| Catalog Number | 8637-40 |
| Device Expiration Date | 2015-11-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Hospitalization | 2020-03-27 |