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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 Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2017
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) via a clinical study regarding a patient receiving dilaudid 1.5 mg/ml for a total dose of 0.2999 mg/day and bupivacaine 30 mg/ml for a total dose of 5.997 mg/day via an implantable pump for non-malignant pain.It was reported on (b)(6) 2017 during a pump refill, device interrogation/device data revealed a pump reservoir volume discrepancy w here the interrogated reservoir volume (irv) was 20.8ml and the actual aspirated volume (aav) was 24ml.On (b)(6) 2018 during a pump refill, device interrogation/device data revealed a pump reservoir volume discrepancy where the irv was 18.9ml and the aav was 25ml.It was noted that no associated symptoms were reported.No further diagnostics were performed/no action was taken.The outcome of the event was unresolved with no further actions planned.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The event date was (b)(6) 2017.No further complications were reported/anticipated.There was additional information reported that was not relevant to this event and therefore was omitted.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from healthcare professional (hcp) via a clinical study indicated on (b)(6)2018 the patient presented for a pump adjustment secondary to increased lower back pain/worsening pain.A reservoir volume discrepancy was noted at their last refill on (b)(6)2018.The patient's volume was checked at this visit ((b)(6)2018) and device interrogation/device data revealed a 3ml volume discrepancy.It was noted that the patient will be scheduled for pump replacement.No action was currently taken.The outcome of the event was noted as ongoing.The clinical diagnosis was decreased therapeutic effect.The cause of the volume discrepancies was not determined.The patient's baseline weight was (b)(6)pounds.No further complications was reported/anticipated.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, 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 Key7448159
MDR Text Key106655618
Report Number3004209178-2018-08518
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
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,study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/17/2018
Initial Date FDA Received04/20/2018
Supplement Dates Manufacturer Received04/30/2018
Supplement Dates FDA Received05/02/2018
Date Device Manufactured08/15/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age39 YR
Patient Weight83
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