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U.S. Department of Health and Human Services

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

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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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 Key6938555
MDR Text Key89179326
Report Number3004209178-2017-21554
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
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 Date07/14/2011
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/20/2017
Initial Date FDA Received10/10/2017
Date Device Manufactured01/25/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
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