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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 Problem Volume Accuracy Problem (1675)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/04/2018
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 health care provider (hcp) via a device manufacturer representative regarding a patient receiving an unknown drug at an unknown concentration and dose via an implantable infusion pump. The indication for use was noted to be spinal pain. It was reported volume discrepancies over the past 3 refills (dates unknown). Per the caller, the actual residual volumes were greater than the expected residual volumes by 3. 7ml, 5ml and "7mls more/underinfusion. " it was unknown if the patient had experienced any symptoms. No further complications were reported.
 
Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via a manufacturer representative on 2018-jun-13. It was reported that the volume discrepancy was first noticed on (b)(6) 2018. It was noted that on (b)(6), the actual reservoir volume (arv) and expected reservoir volumes (erv) were "6. 5/3. 1ml" and the patient started to report increases in pain. The patient's weight was (b)(6) at that time. On (b)(6) the arv and erv were "6/2. 3ml" and the patient reported no relief from a 100mcg increase. No changes were made, and the patient's weight was (b)(6) at that time. On (b)(6) the arv and erv were "11/6. 1ml" and the patient experienced increased thoracic pain. The dose was increased by 100mcg and the patient's weight was (b)(6) at that time. On (b)(6), the arv and erv were "9/2. 2ml" and the patient experienced relief for a short period of time. The dose was increased by 100mcg and the patient's weight was (b)(6) at that time. The cause of the volume discrepancies was unknown, and a catheter dye study was being ordered. Further imaging and therapies were ordered but due to limited medical coverage, the patient was unable to "do. ".
 
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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 Key7591463
MDR Text Key110869340
Report Number3004209178-2018-13174
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2014
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 Received06/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/05/2013
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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