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 2020-03-25 for SYNCHROMED II 8637-20 manufactured by Medtronic Puerto Rico Operations Co..
[184860390]
Concomitant medical products: product id: neu_unknown_prog, serial#: unknown, product type: programmer, physician, other relevant device(s) are: product id: neu_unknown_prog, serial/lot #: unknown, ubd: unknown, udi#: unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184860391]
Information was received from a consumer via a company representative (rep) regarding a patient receiving intrathecal gablofen 2000 mcg/ml at 378. 3 mcg/day via an implanted pump. It was reported the event/difficulty occurred on (b)(6) 2020 during normal use. It was reported the patient presented in the emergency room (er) and he was having some withdrawal symptoms, including increased tone and difficulty speaking. The patient said that they had the pump refilled a little over a week ago and thought that they did not set the dosing appropriately. It was noted the rep met the patient in the er and read the pump. The pump was filled with baclofen 2000 mcg/ml and dosing at 378. 3 mcg/day. The rep tried connecting with the managing physician? S office to determine if this dosing was appropriate, but unfortunately was not able to contact them. The rep had talked to one of the charge nurse? S and there was some confusion related to the patient? S pump management. The rep told the patient in the er and the nurses that would be a good idea for the patient to follow up with and be evaluated by the physician managing the pump. The pump print outs were provided to the patient, and the er nurses for the patient? S chart. It was unknown if the issue was resolved at the time of this report. It was noted surgical intervention did not occur and it was asked and unknown but would not be made available (legal/confidential reason) if surgical intervention was planned. The patient? S status was? Alive- no injury.? The patient? S weight and medical history were also asked unknown and would not be made available (legal/confidential reason). No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[186458053]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186458054]
Additional information was received via a healthcare provider. It was reported that they were uncertain what clinician programmer was used on (b)(6) 2020 and their emergency department (ed) note indicated a company representative was consulted. It was further noted that on (b)(6) 2020, the new clinician programmer tablet / software application had been used at the clinic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06101 |
| MDR Report Key | 9878001 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-25 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-03-14 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2019-08-05 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | 8637-20 |
| Catalog Number | 8637-20 |
| 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 | 2020-03-25 |