MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for SYNCHROMED II 8637-20 manufactured by Medtronic Puerto Rico Operations Co..
[186070951]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186070952]
Information was received from a consumer on 2020-mar-18 regarding a patient receiving morphine (1. 99mg/day at an unknown concentration) and bupivacaine (dose and concentration unknown) via an implanted infusion pump. It was reported that the patient's pump was "loose" and was moving around inside causing the patient pain. The patient had no problem in 2020-jan and their refill was fine, so they think the issue began in (b)(6) 2020. At a refill on (b)(6) 2020, the pump was flipped over and the healthcare provider (hcp) had to flip it to fill it. The patient was not given any oral meds for the pain associated with the flipping pump and the hcp was reportedly worried about the catheter disconnecting from the pump moving. The patient was scheduled for a revision on (b)(6) 2020, however, the surgery was deemed non-essential and was cancelled due to covid-19. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06442 |
| MDR Report Key | 9902874 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2017-05-20 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Model Number | 8637-20 |
| Catalog Number | 8637-20 |
| Device Expiration Date | 2018-11-14 |
| 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 | 1. Required No Informationntervention | 2020-03-31 |