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

Model Number 8637-20

Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2018

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 patient via a manufacturer¿s representative (rep) regarding a drug infusion device.The drug being delivered was 5 mg/ml dilaudid at 2.0 mg/day (simple continuous plus pa doses 0.5 mg/bolus q10 min 12 doses/ 24 hours).The reason for use was malignant pain and head/neck (non-malignant).It was reported that the ptm displayed the code 8286.The issue started on (b)(6) 2018.It was reviewed the code meaning was for empty reservoir.It was unknown if the patient was due for a refill.The patient did not think she was due for refill until next week.The rep was to follow up with the healthcare professional (hcp) to check when the patient is due for a refill.There were no symptoms reported.Additional information was received from the rep, reporting that the patient called the hcp to report that her ptm was not working.The hcp instructed the patient to contact this rep since they thought it was a ptm issue.The patient told the rep that since evening of (b)(6) 2018, when they request a bolus dose, code 8286 appears with an ¿x¿ for no bolus given.The patient was asked if she or their significant other have heard a two tone alarm every 10 minutes, but both stated they had not heard an alarm.The rep confirmed that 8286 meant empty reservoir.The rep then contacted the pain manager to request info on last pump reprogramming.The patient was seen on (b)(6) 2018 for one week post implant follow up.The doctor doubled her daily dosage and ptm dosages that day, but failed to print out session data and did not look to see the low reservoir alarm date.The reservoir alarm set at ¿1 ml med date of alarm (b)(6) 2018.¿ the doctor told the staff to schedule the patient for follow up (b)(6) 2018.There were no falls or environmental factors that may have led or contributed to the issue, and it was noted that it was ¿strictly human error.¿ the patient was approximately a two hour drive from the clinic so the rep and doctor and clinic staff waited for the patient to arrive at 18:15 on (b)(6) 2018.The doctor had ordered refill medicine ¿hydromorphone 10 mg/ml in pf saline 20 ml¿ through the pharmacy.The rep interrogated the pump, which indicated empty reservoir alarm had sounded and low reservoir alarm sounded.The physician filled the pump, and kept same dosage as programmed on (b)(6) 2018 and programmed bridge bolus since drug concentration changed from 5 mg/ml hydromorphone to 10 mg/ml hydromorphone.After the update completed, the rep used an 8840 to activate non critical alarm and critical alarm so that the patient could hear how they sound.Neither the patient or their significant other could hear due to age related hearing deficits.Surgical intervention did not occur and it was not planned.The issue was resolved at the time of this report.The patient¿s weight was asked and unknown, and it would not be made available.The patient status was listed as ¿alive ¿ no injury¿ and the device was ¿implanted-remains in service.¿ patient medical history was noted to include ¿history laryngeal ca with laryngectomy, ca mets to bones.¿ there were no symptoms reported.There were no further complications 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: 7437302
• MDR Text Key: 105884663
• Report Number: 3004209178-2018-08221
• 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: Other
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2018
• Date Device Manufactured: 12/28/2017
• 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 Age: 68 YR