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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 Failure To Service (1563); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)
Patient Problems Therapeutic Response, Decreased (2271); Weight Changes (2607)
Event Date 04/01/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional (hcp). It was reported that because the pump battery died (clarified as referring to the low battery reset), the hcp elected not to refill or replace the pump. However, because the patient's family wasn't returning calls, the patient ran out of medication for 2 weeks. Per the hcp, the patient's weight wasn't available as they weren't able to weigh her, but she had lost a lot of weight. No further complications were reported.
 
Manufacturer Narrative
Date of event is an estimate. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient who was receiving bupivacaine (5 mg/ml, 1. 99 mg/day) and morphine (50 mg/ml, 19. 99 mg/day) via intrathecal drug delivery pump for non-malignant pain and failed back surgery syndrome. It was reported that the patient had been without medication for over 2 weeks as the pump was not refilled. The pump was interrogated and noted to be in safe state. The low reservoir and empty pump alarms occurred, as well as low battery reset and safe state. The pump logs were checked. The hcp asked to program the pump off permanently and successfully programmed the pump off. The patient's withdrawal was over and the patient was appearing comfortable. The pump was refilled about every 3 months and the reset happened after the most recent refill. The empty pump occurred "about 2 weeks ago. " no further complications were reported.  .
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7465521
MDR Text Key106696489
Report Number3004209178-2018-09380
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 health professional
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2012
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/19/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3043-2011

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