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

Model Number 8637-40

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problems Fall (1848); Pain (1994); Loss of Vision (2139); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 06/10/2017

Event Type  Injury  

Event Description

Information was received from a patient who was receiving 50 mg/ml of morphine at an unknown dosage via an implantable pump for non-malignant pain and failed back surgery syndrome.On (b)(6) 2017, it was reported that the patient's pump ran dry, the battery died, and the patient went through morphine withdrawal.It was reported that the patient's pump ran out and they started to go through withdrawal on (b)(6) 2017.According to the patient the battery went dead.The patient wanted the pump out as it had run out of medication and the battery had run out.The patient noted that they had been on a high dose of morphine in the pump for 12 years and was not weaned off the morphine before they "detoxed".According to the patient, they are now blind and their eye sight issues are due to the morphine withdrawal.Additionally, the patient's kidney was "shot".According to the patient, they are going to the hospital because their liver is also shot due to the ordeal they went through.The patient reported that they could not walk, they were "as tired as a bat", and that the pump was giving them pain and discomfort.The pump was reportedly pushing against the patient's back.The patient also reported that they needed their stomach pumped as it was really swollen and fluid.According to the patient, as a result of the morphine "detox", the patient's hair turned grey, they almost died, their heart "took a beating", and they fell on the floor at their son's graduation.The patient noted that the pump alarms occasionally when it warms up, stating that when the patient takes a hot shower or gets into a hot tub, the alarm goes off.Likewise, the battery "comes back to life" and alarms when the patient is in bed.According to the patient, the pump was alarming less and less.The patient was enquiring about having the pump alarm turned off.No further complications were reported.

• 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: 6938555
• MDR Text Key: 89179326
• Report Number: 3004209178-2017-21554
• 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
• Type of Report: Initial
• Report Date: 10/10/2017

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: 07/14/2011
• 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: 09/20/2017
• Initial Date FDA Received: 10/10/2017
• Date Device Manufactured: 01/25/2010
• 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 Outcome(s): Other
• Patient Age: 60 YR