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 2020-03-30 for SYNCHROMED II 8637-40 manufactured by Medtronic Puerto Rico Operations Co..
[185489802]
Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2020, product type: catheter. Product id: 8709, serial#: (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 13-jul-2012, udi#: (b)(4); product id: 8709, serial/lot #: (b)(4), ubd: 08-jun-2008, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185489803]
Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving baclofen (300 mcg/ml at 177. 168 mcg/day) and morphine (25 mg/ml at 14. 764 mg/day) via an implanted pump. It was reported that last friday ((b)(6) 2020) the patient went into withdrawal. Sometime after that the patient went for a ct scan which showed catheter breakage. The catheter was replaced today ((b)(6) 2020). No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06344 |
| MDR Report Key | 9896834 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-20 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2020-01-30 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Model Number | 8637-40 |
| Catalog Number | 8637-40 |
| 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 | 2020-03-30 |