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 Dyspnea (1816); Overdose (1988); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Cognitive Changes (2551)

Event Date 11/06/2018

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 healthcare provider (hcp) via a company representative regarding a patient who was receiving bupivacaine with concentration 20 mg/ml at a dose rate of 10 mg/day and dilaudid with concentration 3 mg/ml at a dose rate of 1.5 mg/day via an implantable pump for spinal pain.It was reported that the patient had a pump refill on (b)(6) 2018 with a change in medication.The patient presented to the emergency room (er) on (b)(6) 2018 with slowed breathing.The company representative was contacted on (b)(6) 2018 to turn the patient¿s pump down to minimum rate.The pump turned down to minimum rate and the dose rate of bupivacaine was decreased from 10 mg/day to 0.124 mg/day and the dose rate of dilaudid was decreased from 1.5 mg/day to 0.0186 mg/day.The cause of event was undetermined.No surgical intervention occurred, and no surgical intervention was planned.The issue was resolved at the time of the report.The patient was without injury regarding their status at the time of the report.Other medications (oral, etc.) the patient was taking at the time of the report was unable to be obtained.The patient¿s medical history was indicated as having been requested but was unknown.It was noted that the hcp had no further information.No further patient complications have been reported as a result of this event.2019-04-22 additional information was received from a consumer.The date of event was (b)(6) 2018.The pump was filled on (b)(6) 2018.The medication was adjusted as the patient asked the healthcare provider to "bring it up a notch".The patient went to the hospital the next day for an endoscopic that went down her throat.The doctor asked if she was feeling all right because she was showing that she had dilaudid in her system.The patient was not aware that the drug was changed to dilaudid.The patient thought the drug was morphine.The patient was taking oral medications also.The patient was "overdosed".The patient experienced withdrawals and hallucinations due to this issue.The patient was treated at a hospital.The patient was discharged from the hospital on (b)(6) 2018 but still felt "out of it completely".It was clarified there was no allegation again the pump.The patient reported ¿the pump is the best thing to happen to her life¿.The situation was resolved.The pump was previously delivering dilaudid and two other unknown narcotics.The patient has 30-40% capacity/use of her lungs.It was confirmed this issue began prior to implantation of her pump.The pump was currently delivering morphine.

• 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: 8560107
• MDR Text Key: 143391954
• Report Number: 3004209178-2019-08470
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2019
• Date Device Manufactured: 05/21/2018
• 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: 76 YR
• Patient Weight: 74