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

Model Number 8637-40

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Syncope (1610); Chest Pain (1776); Dyspnea (1816); Pain (1994); Weakness (2145); Tingling (2171); Chills (2191); Complaint, Ill-Defined (2331); 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 regarding a patient who was receiving morphine, bupivacaine, and sufentanil via an implantable pump for non-malignant pain.The following was read from an april printout: morphine 3.271 mg/day, bupivacaine 3.271 mg/day, and sufentanil 32.71 mg/day.The following was further read: morphine 15.0 ¿mg/mg¿, bupivacaine 15.0 ¿mg/mg¿, and sufentanil 150.0 ¿mg/mg¿.Drug concentrations were unknown.It was described that the patient had the same medication back 2-almost 3 years ago, but the it was a lesser dose.It was reported the patient¿s spine was fused, and it did not work and, therefore, they put the pump in.When the patient first went to their physician they put morphine in her body and not in her pump.The date of event was unknown, described as having occurred 2-almost 3 years ago.When asked at the time of the report if this was suspected or if this was confirmed, the reporter noted this was her assumption that medicine did not go to the right place because she had all these symptoms.The symptoms were not regular but often.It was further reported that the patient felt the same thing that she feels off and on or when her pump had turned off for an hour or two and she guesses the pump is not passing the medication.The patient had all those symptoms and that¿s what she felt when she first went to her physician like 2 almost 3 years ago when the healthcare provider (hcp) thought he had put it in the pump; she started to feel like she was going to pass out, very weak.The patient stayed in the office and after 20-30 min she was back to normal and they took care of her.It was further described that all symptoms that the patient has were not regular, but way often, and now they are more regular these past 4 months.For the last 3 to 4 months, the patient had been having episodes and nobody could figure out what was wrong with her.The patient would feel like her whole blood is drained out and she cannot breathe; it starts like that and that¿s how she felt in the past 3 to 4 months.It was further noted that she starts feeling like chills, her chest is hurting, she cannot breathe.Slowly that goes away.The patient also feels like a million ant bites from the waist down.The patient feels pain all over / everywhere, her ¿back wants to break¿, and she cannot stand on her legs.The patient had been checked out ¿everywhere¿, by her hcp and yesterday ((b)(6) 2018) at the hospital.The patient had a severe episode yesterday when she went to the hospital.Yesterday was her worst episode.She was on the floor with so much pain, she could not stand it.Yesterday the hospital ran blood tests, ekg, everything to find out what is wrong.They told her in their opinion there is something wrong with her morphine pump not working correctly and not giving her enough medicine.It was noted that the pump was to expire in july and the patient was supposed to have it replaced on (b)(6).The patient had contacted their physician and they gave the patient a company representative¿s phone number to come look at the patient¿s pump; however, the patient was not home.It was further noted that now they told the patient to call the manufacturer¿s 800 number, provide her zip code where she was located, and see if they can get a representative from that area to come out and test her pump.The reporter was redirected to their hcp to contact the company representative.No further patient complications have been reported as a result of this event.The patient¿s medical history included: spine was fused.

Manufacturer Narrative

Correction: these fields were not completed in error regarding the initial report.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.

• 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: 7666567
• MDR Text Key: 113516062
• Report Number: 3004209178-2018-15165
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• 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: 08/08/2018
• Date Device Manufactured: 09/16/2011
• 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-1060-2011
• Patient Sequence Number: 1