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 2020-03-31 for SYNCHROMED II 8637-40 manufactured by Medtronic Puerto Rico Operations Co..
[185718310]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185718311]
Information was received from a consumer via a manufacturer representative (rep) regarding a patient receiving dilaudid (hydromorphone) 5 mg/ml with an unknown dose and bupivacaine 5 mg/ml with an unknown dose via an implantable pump. It was reported the patient called on (b)(6) 2020 questioning potential infection. The doctor was notified and instructed the patient to come to the office first thing in the morning. The patient reported changing bandage and pulling scab off incision. Clear fluid began leaking and over a few days the clear liquid started showing signs of infection. The patient also reported redness around the indication as well as bakst chills. All of the symptoms were reported to the physician. The patient was seen the next morning to access and emergency surgery was scheduled to remove the pump. The patient was started on antibiotics until they could be seen for examination. During the examination, it was determined surgery was needed to remove the pump. Surgical intervention occurred where the pump was explanted and not replaced on (b)(6) 2020. The issue was resolved at time of report. The patient's status at time of report was alive-no injury. The patient's medical history was asked, but unknown. The event date was (b)(6) 29. No fur ther complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06441 |
| MDR Report Key | 9902863 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-29 |
| Date Mfgr Received | 2020-03-29 |
| Device Manufacturer Date | 2019-08-19 |
| 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 |
| 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 | 2020-03-31 |