MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Complaint, Ill-Defined (2331); Malaise (2359); Reaction (2414); Cognitive Changes (2551)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was receiving morphine of unknown concentration at an unknown dose rate via an implantable pump for non-malignant pain and failed back surgery syndrome.It was reported that the started feeling sick after the pump was implanted.The patient thought she was allergic to the medication, but the reporter (friend/family member of the patient) though the patient was not thinking straight.It was further indicated that there are other factors (not specified) that were causing the sickness.The patient had gone to their healthcare provider (hcp) on (b)(6) 2019 and they turned the pump down to its lowest dose.The patient went back to the hcp on (b)(6) 2019 and the hcp told the patient he had turned the pump off.The patient had gone to the emergency room on (b)(6) 2019 and was admitted to the hospital on (b)(6) 2019.The patient had been hospitalized for three days and got out of the hospital on (b)(6) 2019.Regarding the patient¿s current status however, it was indicated that the patient was hospitalized.The patient still felt sick and the reporter was wondering if the patient was still getting medication from her pump.The reporter wanted to confirm if it was possible that the patient might be getting medication from the pump.They had tried calling the hcp, but he was on vacation.No further patient complications have been reported as a result of this event.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8505966
• MDR Text Key: 141662169
• Report Number: 3004209178-2019-07215
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/11/2019
• Date Device Manufactured: 01/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR