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 2020-03-26 for SYNCHROMED II 8637-20 manufactured by Mdt Puerto Rico Operations Co.
[185211883]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185211884]
Information was received from the consumer via a device manufacturer representative (rep) regarding a patient receiving compounded baclofen (unknown concentration at 50 mcg/day) via an implantable infusion pump. It was reported that the patient had been feeling more stiff lately. It was noted that the healthcare provider (hcp) recently lowered the dose from 150 to 50 mcg/day. Additional information was received from a healthcare provider (hcp) via the rep indicated the patient did not recently have an mri, but the patient? S managing doctor interrogated the pump on the date of this report during a refill and the pump was showing stalled 800 days after the mri. The potential for telemetry state was reviewed. It was recommended to re-interrogate the pump to see if a recovery message appeared. It was noted the rep was arriving at the patient? S appointment during the call. It was confirmed the pump had not been alarming. The patient had been feeling stiffer recently, but the rep did not know when this started. The patient recently had their dose lowered from 150 mcg/day. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06228 |
| MDR Report Key | 9886346 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2013-08-27 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | 8637-20 |
| Catalog Number | 8637-20 |
| Device Expiration Date | 2015-02-14 |
| 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 | 2020-03-26 |