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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 Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) regarding a patient who was receiving hydromorphone (3mg/ml at 0. 9993mg/day) and bupivacaine (25mg/ml at 8. 327mg/day) via intrathecal drug delivery pump. The indication for use was noted as non-malignant pain and other non-malignant pain. It was reported that the actual reservoir volume (arv) was greater than the estimated reservoir volume (erv). The volume discrepancy was at the pump refill on (b)(6) 2018. The arv was 8. 1ml and the erv was 2. 9ml. The levels had been pretty accurate/very close until (b)(6) 2018. The event logs were normal and it did not look like the pump had been updated at the time of the back surgery. The hcp had not made a mistake with programming or "anything like that. " the hcp wondered if the procedures for the patient back surgery 3-4 weeks prior/pretty recently could have caused this volume discrepancy. The patient wanted to get off oral medications from the surgery so the intrathecal (it) daily dose was increased (b)(6) 2018 after the surgery and also a 9% increase on (b)(6) 2018. No symptoms were reported. This was not the first refill after implant/revision. The patient would be brought back early to check the volume and the hcp would monitor the patient. There were no further complications reported at this time.
 
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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 Key7473675
MDR Text Key106920652
Report Number3004209178-2018-09649
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
Type of Report Initial
Report Date 04/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2014
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/03/2012
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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