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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 Pumping Stopped (1503); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (managing nurse) regarding a patient who was previously receiving an unspecified drug of an unspecified concentration at an unspecified dose rate via an implantable pump for chronic low back pain and non-malignant pain. Regarding the patient¿s current pump, it was noted that the patient was currently receiving fentanyl with concentration 3000 mcg/ml at a dose rate of 1650 mcg/day it was reported they had seen some volume discrepancies of 3. 5 to 4 ml with the patient¿s current pump and even with the patient¿s prior pump. Refer also to mfr report 3004209178-2018-15959 regarding volume discrepancies with current pump. It was further reported that they did not have a specific date of when the volume discrepancies of 3. 5 to 4 ml began, but there was a historical precedent. No patient symptom was reported. No further patient complications have been reported as a result of this event. Additional information was received from a healthcare provider (hcp). The patient had a history of chronic pain syndrome and multiple back surgeries. It was reported that the cause of the volume discrepancies were unknown. The motor stalled with 4 months on elective replacement indicator (eri) and the pump was replaced. The volume was greater than expected. The first time noticed larger than 3ml was in (b)(6) 2018. Then it was consistent 3. 5-4ml after that date. No symptoms were experienced. There were no further complications reported at this time.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7752779
MDR Text Key116110707
Report Number3004209178-2018-17461
Device Sequence Number0
Product Code LKK
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2011
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/16/2009
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: 08/06/2018 Patient Sequence Number: 1
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