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

Model Number 8637-20

Device Problems Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015)

Patient Problem Pain (1994)

Event Date 03/26/2017

Event Type  Injury  

Event Description

Information was received from a consumer via a company representative regarding a patient receiving an unknown drug via an implantable pump.The indications for use were non-malignant pain and failed back surgery syndrome.The patient reported a code on the ptm (personal therapy manager), 8474, pump reset.On sunday (b)(4) 2017, the company representative received a text from the office manager at the clinic requesting they contact the patient as the patient had left a message with the office answering service that their pump was beeping.The company representative called the patient and discovered a critical alarm was occurring, ptm code 8474 (pump reset).The patient reported their pump was refilled on (b)(6) 2017 and thought that 14ml¿s were aspirated.The pump was refilled and updated.The patient used their ptm on (b)(6) 2017 and worked fine but on (b)(6) 20147 started beeping and the ptm code 8474.The patient¿s pain was increasing.There were no environmental, external or patient factors that may have led or contributed to the issue, no falls etc., reported.The patient¿s pump manager was notified and was having the patient take oral morphine, dose and concentration unknown, and scheduled the patient for symptom consult in the clinic on (b)(6) 2017.The company representative requested they be notified of the time of the appointment so they could be present to read the pump logs.Surgical intervention did not occur and it was unknown if surgical intervention was planned.The issue was not resolved at the time of the report and the patient¿s status was noted as alive, no injury.No further patient complications have been reported as a result of this event.

Event Description

Additional information was received from a manufacturer's representative (rep).It was reported the patient had a symptoms consult with a healthcare provider on (b)(6) 2017 at 13:00.A rep read the logs and the pump was in safe mode delivering medicine at minimum rate.The logs indicated the pump was in "safe mode low battery." the patient was awaiting insurance prior authorization for the pump replacement.The patient was put on oral morphine.No further complications were anticipated/reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer and the manufacturing representative on (b)(6) 2018.The patient reported their pump was turned off the year before, either 2016 or 2017, because the pump was malfunctioning.When asked for clarification regarding the malfunction, the patient said the alarm kept going off on their pump and the manufacturing representatives had to shut the alarm off twice (please refer to mfr report number 3004209178-2016-10436 regarding the 2016 low battery reset report).The patient reported they were supposed to have surgery and have the pump removed on (b)(6) 2017.However, the patient did not have the pump removed because they got ill.The patient said their white count was up.The patient stated this illness was not related to the pump or therapy.The patient was at the doctor on (b)(6) 2017, due to the pump alarming.It was reported the pump was alarming or beeping at the time of the report ((b)(6) 2018).The patient stated the pump had started alarming again probably two months earlier, and the dual alarm started to alarm continuously within the past week.The patient stated sometimes the alarm was loud and sometimes the alarm was low.The patient did not know why the pump was alarming again because they had met with a rep twice and had the pump turned off.The patient reported their pump was near the elective replacement indicator (eri).The patient was directed to follow-up with their healthcare provider (hcp).No symptoms were reported.It was indicated the drug was removed from the pump six to nine months earlier, and the patient reported they did not put saline in the pump.The patient was till going to the pain clinic for oral medication and was getting injections in their lower spine and neck.On (b)(6) 2018 the rep reported the patient¿s pump had been stopped some time ago and the patient had not been using the pump for therapy.The rep was contacted by the patient that day ((b)(6) 2018) and reported their pump was alarming and they would like to have it turned off.The rep reported the alarm began roughly a month earlier.Technical services reviewed that based off the implant date, the pump should have been alarming due to end of service (eos).Technical services reviewed that once eos occurs there was no need for a password to shut off the pump.The rep was redirected to follow-up with the healthcare provider to review considerations.The rep stated the patient did not have a managing healthcare provider for the pump because the patient had not been getting refills for some time.The pump off authorization form was sent to the rep.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative.It was reported that the patient's pump was permanently turned off around 1:30pm on (b)(6)2018.Prior to interrogating the pump, it was confirmed with the patient that she wanted the pump turned off permanently, the patient stated yes.She was not using the pump and she was tired of hearing it beep.During the meeting, no pump alarms were heard.The pump was interrogated and it gave an end of service (eos) message.The patient was referred to speak with her physician and his scheduling coordinator regarding how soon she could get on the schedule to have the device removed.There were no further complications reported at this time.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6438456
• MDR Text Key: 70973360
• Report Number: 3004209178-2017-06455
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2012
• 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: 05/22/2018
• Date Device Manufactured: 12/21/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR