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

Model Number 8637-40

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

Patient Problems Pain (1994); Weakness (2145); Therapeutic Response, Decreased (2271); Distress (2329); Ambulation Difficulties (2544)

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 consumer (con) regarding a patient receiving an unknown drug of an unknown concentration and dose via an implantable infusion pump for non-malignant pain.It was reported that the patient had been discharged by their doctor that maintained the pump.The patient had begun to bring up issue there were having with the pump.The patient had begun to have mobility issues and what seemed like some type of growth in the attachment area of the spine.The patient could not make it to their last appointment for a fill.The patient lost their driver's license due to possible seizures.The doctor lived a pretty decent distance from the patient thus making it difficult for the patient to see the doctor.That was the reason the patient was given for discharge.Now the patient was getting the six tone variable warning.There was nowhere for the patient to go at this point.The alarm itself was keeping the patient up at night.That with the expired medicine and eventually of complete therapy on the horizon constantly looming over the patient had left the patient somewhat distressed.The patient wanted to know if there was some way to stop the alarm and find someone to service it.No further complications were expected or anticipated.Additional information was received from the patient and a manufacturer¿s representative (rep) on (b)(6) 2018.The drug being delivered was hydromorphone at an unknown dose and concentration.It was reported that the pump was alarming/beeping for ¿maybe 3 weeks¿ because the pump is empty and recently ran out of medication.The patient believes the pump had been empty for ¿2-3 days¿ prior to the call date.The patient missed a scheduled refill.The patient was dismissed by the managing healthcare professional (hcp) due to a missed appointment.The reason for the missed appointment was because ¿he is not able to drive due to a history of seizure.¿ the patient asked if there is any way for him to shut the alarm off, it was reviewed that it can only be addressed with the clinician programmer.The caller was to follow up with the hcp.Hcp listings were provided to the patient, and it was recommended that they seek medical care for symptoms, as they stated he is ¿really close to going to an er or something.¿ the patient reported that they had got ten ¿so weak and has been experiencing withdrawal symptoms.¿ these symptoms had occurred for the ¿last 4 days¿ prior to the call date.Additional information was received from the rep on the same day.They were with the doctor and the doctor stated they patient was dismissed for missing ¿many, many¿ appointments, not just one.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a health care provider (hcp) on 2018-jul-23.It was reported that the patient came into the office to be evaluated for back pain.The patient had been fired from his pain pump doctor and did not currently have a managing physician.The patient's pump was alarming with an empty pump alarm.The patient had already gone through withdrawal.No further complications were reported.

Manufacturer Narrative

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

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7609459
• MDR Text Key: 111326925
• Report Number: 3004209178-2018-13610
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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: 10/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 07/23/2018; 08/08/2018
• Supplement Dates FDA Received: 07/24/2018; 10/03/2018
• Date Device Manufactured: 05/03/2012
• 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