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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); Aspiration Issue (2883)
Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8711, lot# n107681008, product type: catheter; product id :8731sc, serial# (b)(4), product type: catheter. Other relevant device(s) are: product id: 8711, serial/lot #: n107681008, (b)(4); product id: 8731sc, serial/lot #: (b)(4), (b)(6), (b)(4). 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 morphine 20mg/ml for a total dose of 5. 262 mg/day and bupivacaine 10mg/ml for a total dose of 2. 631 mg/day via an implantable pump for non-malignant pain and failed back surgery syndrome. It was reported on (b)(6) 2017 upon examination that a pump reservoir volume discrepancy occurred where the expected residual volume (erv) was 3. 4 and the actual residual volume (arv) was 6. 4. The patient had no symptoms. Expected 3. 4, actual 6. 4. Patient presents no symptoms. No action was taken. The outcome of the event was ongoing. The etiology of the event indicated the relationship of the event to the device or therapy was possibly related and indicated the relationship of the event to the implant procedure was unlikely related. It was noted to be due to programming/refill. The event date was (b)(6) 2017. No further complications were reported/anticipated. Additional information received from a healthcare provider via a clinical study reported the patient's catheter was revised on (b)(6) 2018. It was noted the event resolved without sequelae on (b)(6) 2018.
 
Manufacturer Narrative
Product id 8711, lot# n107681008, implanted: explanted: product type catheter, (b)(4), product id 8731sc, (b)(4) implanted: explanted: product type catheter (b)(4). 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 2017-dec-04 a catheter evaluation revealed they were unable to aspirate from the catheter/catheter unable to be aspirated. It was noted that the patient presented at their next appointment on (b)(6)2017 with withdrawal symptoms. The reason for the catheter revision was because they were unable to aspirate from the catheter. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study indicated the cause of the unable to aspirate from the catheter was not determined. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information received from a healthcare professional (hcp) via a clinical study indicated the device diagnosis was updated to pump unable to enter/withdraw from catheter access port. No further complications were reported.
 
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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 Key7437864
MDR Text Key105723189
Report Number3004209178-2018-08238
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100831
UDI-Public00643169100831
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
Type of Report Initial,Followup,Followup,Followup
Report Date 10/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2014
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received10/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/20/2013
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: 04/17/2018 Patient Sequence Number: 1
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