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

Model Number 8637-40

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988); Oversedation (1990); Scar Tissue (2060); Loss of consciousness (2418); Decreased Respiratory Rate (2485)

Event Date 02/26/2019

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 healthcare provider via a company representative regarding a patient who was receiving dilaudid with concentration 10 mg/ml at a dose rate of 0.062 mg/day via an implantable pump for non-malignant pain and other chronic/intractable pain (trunk/limbs).It was reported that oversedation occurred.It was further noted that as per a healthcare provider, the patient had their medication changed in the pump on (b)(6) 2019 from tramadol to hydromorphone.A bridge bolus was programmed and was to last approximately 51 hours.Per a nurse, on (b)(6) 2019 around noon the patient was noted with decreased level of consciousness (loc).Their blood pressure and respirations were decreased.The patient was briefly arousable to loud auditory stimulation.There was expressed concern that the patient may have accessed the pump through the refill port himself as there was a newly formed scab over the port.No diagnostic tests/troubleshooting were performed.Actions taken to resolve the issue included the pump having been decreased to a minimum rate from 0.5 mg/day.No surgical intervention occurred, and no surgical intervention was planned.It was unknown if the issue was resolved at the time of the report.The patient was without injury regarding their status at the time of the report.As per the pump logs provided, hydromorphone with concentration 10.0 mg/ml was being administered at a dose rate of 0.500 mg/day as of (b)(6) 2019.Other medications (oral, iv, etc.) the patient was taking at the time of the event included oxycontin once in the morning at an unknown dosage.The patient¿s weight at the time of the event was unknown.The patient¿s medical history included chronic pain.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: 8447899
• MDR Text Key: 139695313
• Report Number: 3004209178-2019-05916
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2019

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: 01/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/25/2019
• Date Device Manufactured: 08/01/2017
• 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): Other
• Patient Age: 56 YR