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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 8637-20
Device Problems Premature Elective Replacement Indicator (1483); Inappropriate or Unexpected Reset (2959); Mechanical Jam (2983)
Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information received from a healthcare provider (hcp) regarding a patient receiving clonidine 42mcg/ml at 10. 232mcg/day, bupivacaine 22. 5mg/ml at 5. 481mg/day, and dilaudid 20mg/ml at 4. 872mg/day via an implanted pump. Indication for use was noted as non-malignant pain and degenerative disc disease/herniated disc pain. It was reported that on (b)(6) 2017, an alarm was heard and confirmed by telemetry. The pump logs were checked. The alarm was a critical alarm. A low battery reset occurred and reset occurred. As of (b)(6) 2017, no symptoms were reported. It was also reported that a motor stall was seen at initial interrogation, the motor stall had not recovered but it had been less than 2 hours since the patient exited the mri field. Per the hcp, the reason for the mri was not related to a suspected problem with the mdt device or therapy. Additional information received from the consumer patient on (b)(6) 2017, stating that on (b)(6) 2017, they went in and got an mri d one. The pump was alarming. The patient went to their healthcare provider's (hcp) office to have the mri checked post status mri. The patient found out that the "pump battery died" on (b)(6) 2017 (due to pump elective replacement indicator on logs) and the patient was running on reserves. The patient had oral medications that they were using for breakthrough and wasn't provided with anymore. The patient stated they have a surgical consultation on (b)(6) 2017 for pump replacement. The reason for mri was because the patient was having increase pain and "other conditions. " since (b)(6) of 2016, the patient had had increase in pain symptoms and other issues arise that the patient needed checked out. On (b)(6) 2017, the patient had been feeling flu like symptoms and did try to call their hcp but had not heard back from them.
 
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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 Key6517419
MDR Text Key103238803
Report Number3004209178-2017-08962
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,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2012
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/25/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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