MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for SYNCHROMED II 8637-40 manufactured by Medtronic Puerto Rico Operations Co..
[185715690]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185715691]
Information was received from a healthcare provider via a company representative regarding a patient receiving baclofen 2250mcg/ml at 129. 8mcg/day via an implantable pump. On (b)(6) 2020 it was reported they read the patient? S pump today and noted loss of therapy from (b)(6) with service code 99 (pump is stopped for 50 hours and 0 minutes) and 100 (pump is currently stalled). Per the reporter, the patient? S condition was noted as? She is quite rigid.? No further complications were reported regarding the event.
Patient Sequence No: 1, Text Type: D, B5
[186673020]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186673021]
Additional information was received on (b)(6) 2020 from a healthcare professional (hcp) who reported that the pump continued in a motor stall state. The hcp requested and was given the pump off passcode because the patient was not having the pump replaced at this time. No further complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[186673148]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188943166]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188943167]
Additional information received reported that the actions and interventions taken to resolve the issue from (b)(6) 2020 was they contacted the manufacturer and were advised to interrogate the device and logs a second time to ensure the device did not require and interrogation before restart of the therapy. They confirmed with staff and the patient that an mri was not completed. The status of the pump on (b)(6) 2020 was noted as the pump had a loss of therapy, the pump was put into minimum rate and the date of the replacement had not been set. No further complications were reported regarding the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06448 |
| MDR Report Key | 9903312 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2015-07-22 |
| 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 | 8637-40 |
| Catalog Number | 8637-40 |
| Device Expiration Date | 2017-01-14 |
| 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 | 2020-03-31 |