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

Model Number 8637-40

Device Problems Device Displays Incorrect Message (2591); Application Program Problem (2880); Human-Device Interface Problem (2949)

Patient Problems Therapeutic Response, Decreased (2271); Anxiety (2328)

Event Date 11/27/2017

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 who was receiving dilaudid at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain.It was reported that the patient was in the hospital and facilities since (b)(6) 2017 with congestive heart failure and had a heart stent put in "almost 8 weeks ago." the patient heard the alarm go off from the pump and confirmed with the patient service specialist (pss) that it sounded like a european ambulance.Pss asked the patient if the stay in the hospital/facilities for congestive heart failure and having the heart stent placed had anything to do with the pump, and the patient stated she didn't think it was related because her "alarm date is (b)(6)" (she spoke to a doctor in florida).The patient mentioned that initially she thought that the alarm she heard had something to do with the heart alarms that she was wearing, but when she came home the day before this report, she did not hear the alarm until the morning of this report when she was in the hospital (she thought the noise was from the machines in the hospital).The patient wanted to get help/assistance on what to do with the pump since it was alarming.The pss reviewed the critical alarm with the patient and played it, and the patient confirmed that was the noise she heard.The patient did not have a healthcare professional (hcp) to check the pump, so pss sent out physician listings.The patient would follow up with the list to find a new doctor and get the pump checked.It was unknown when the patient first noticed the pump alarming.The patient only knew that dilaudid was in the pump and that "40cc" was put in at the time of refill.The patient's pump was only a year old and she had never had a problem before, so she was "nervous" because of the alarm.No further complications were reported.Additional information was received, indicating that the pump was giving a slight beep, which was first noticed on (b)(6) 2017-.The beep was noted as a critical alarm.The patient had followed up with pain management healthcare providers (hcp) on (b)(6) 2017.On (b)(6) 2017, it was found that pump was empty.The cause of the pump alarm was noted as the empty pump with no medication.The pump was refilled with 20 ccs of saline until the medicine was available.The patient went through withdrawal and was given medications to help.The alarm issue was resolved.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer, indicating that the pump was filled on 2017 (b)(4).The patient had follow up appointments on 2018 (b)(6) and 2018 (b)(6).When asked about the cause of the pump alarm, it was noted that the pump was empty and the patient was going through withdrawal.The alarm issue was resolved.The pump was initially filled with saline.A week after the pump was filled with saline, the pump was filled with dilaudid and the pump was programmed accordingly.One light beep was first noticed on 2017 (b)(4).The critical alarm was heard on 2017 (b)(4).It was further reported that the patient moved in 2017 (b)(6) and was told the wrong alarm date.The patient had trouble finding a healthcare provider (hcp) in the area and was hospitalized from 2017 (b)(6) through 2017 (b)(6) with congestive heart failure (chf).The patient reported a (b)(6) pound weight gain due to chf and chronic obstructive pulmonary disease (copd).No further complications were reported.

• 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: 7216588
• MDR Text Key: 98232422
• Report Number: 3004209178-2018-01310
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Date Device Manufactured: 02/04/2016
• 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: 58 YR
• Patient Weight: 167