MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-27 for SYNCHROMED II 863720 manufactured by Mdt Puerto Rico Operations Co.
[186348591]
Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2006, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 03-oct-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
[186348592]
Information was received from a consumer regarding a patient who was receiving an unspecified drug of unspecified concentration at an unspecified dose rate via an implantable pump. It was reported the patient had an infection and the pump and catheter were to be removed. It was noted the catheter couldn't be removed due to the way it was positioned so it was kept implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06300 |
| MDR Report Key | 9891868 |
| Report Source | CONSUMER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2006-11-02 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | 863720 |
| Catalog Number | 863720 |
| Device Expiration Date | 2008-04-28 |
| 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 | 1. Required No Informationntervention | 2020-03-27 |