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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 Kinked (1339); Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2015
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2010, product type: catheter. 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 (unknown concentration and dose) via an implantable pump. Indication for use was spinal pain. The date of the event was unknown. It was reported the patient had a couple of falls and either bent or dislodged the catheter. The pump was close to end of life and they decided to replace the pump as well. The issue was resolved. There was no out of box failure and no medical or therapy problem associated with small parts. No further complications were reported.
 
Manufacturer Narrative
Device codes (b)(4) and patient code (b)(6) are no longer applicable to the event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). The date of the event was approximately (b)(4) 2015. The bent or dislodged catheter was first noticed (b)(4) 2015 status post multiple falls and reported not sufficient pain relief. On (b)(4) 2015 a catheter dye study was done and unit was changed out completely (b)(4) 2015. The unit was not noted to be damaged or bent. A catheter dye study was done with ease, no difficulty. The patient was doing fine now with new unit. The patient¿s weight was noted as morbidly obese. Medical history was severe lumbar stenosis, lumbar degenerative disc disease (ddd) and lumbar radiculopathy.
 
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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 Key7472195
MDR Text Key106863000
Report Number3004209178-2018-09569
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 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2011
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received05/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/08/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/30/2018 Patient Sequence Number: 1
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