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

Model Number 8637-20

Device Problems Device Alarm System (1012); Protective Measures Problem (3015)

Patient Problems Therapeutic Response, Decreased (2271); Malaise (2359)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a from a healthcare professional (hcp) regarding a patient receiving hydromorphone (1 mg/ml at 0.33 mg/day) and bupivacaine (20 mg/ml at 6.6 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.On 21-aug-2019 it was reported that a pump alarm was heard and confirmed by telemetry.The programmer alert showed "pump in safe state, service code 87".The pump logs showed "pump defaulted to minimum rate (07)" on (b)(6) 2019 at 1:17 pm.The patient did not hear the alarm, but her son did.The patient did not hear well and wore hearing aids.Per the hcp, the patient was in withdrawal.She had flu-like symptoms and had not felt well.The hcp was able to enter the prescription information, update the pump, and clear the alert for the pump alarm.She added a single bolus to get the patient some medication right away and the new dosing information was hydromorphone (1 mg/ml at.2517 mg/day) and bupivacaine (20 mg/ml at 5.034 mg/day).No further complications were reported/anticipated.

• 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: 8920011
• MDR Text Key: 155188989
• Report Number: 3004209178-2019-16129
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 08/22/2019
• Date Device Manufactured: 04/25/2019
• 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 Age: 81 YR