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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 No Audible Alarm (1019); Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2017
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8870, serial#: unknown, product type: software. Product id: a810, serial#: not applicable, product type: software. Other relevant device(s) are: product id: 8870, serial/lot #: unknown. Product id: a810, serial/lot #: not applicable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the healthcare provider (hcp) via a device manufacturer representative regarding a patient receiving hydromorphone (20 mg/ml at 4. 3 mg/day) via an implantable infusion pump. The indication for use was non-malignant pain and failed back surgery syndrome. It was reported that since (b)(6) 2017 the pump reports have been displaying "eri occurred, schedule to replace by". It was noted that there were no audible alarms and no volume discrepancies. The caller stated that they would likely schedule a replacement soon but it was not yet scheduled. No symptoms were reported. No further complications have been reported as a result of this event. On (b)(6) 2019 crts update and images x2, e1 (rep): pump logs were received. 8840 logs indicated a "eri occurred, schedule to replace pump by ??/??/????" message and tablet logs indicated "pump has reached the elective replacement indicator (eri). To prevent loss of therapy, schedule to replace the pump by -----. ".
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer's representative (rep) on 2019-may-21. It was reported that the 8840 that was submitted was generated by an 8840 belonging to the clinic, one of 10 to 15 that have been assigned to the clinic. The report was generated in the clinic's system back in 2017. The serial number of the 8840 and the software version number and serial number for the 8870 were unknown. No further complications were reported.
 
Manufacturer Narrative
Additional review/investigation indicates c91397 does not apply to this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Logs also indicated a note that there was an issue with the value from the pump memory which was software related, and a telemetry uplink problem was noted.
 
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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
MDR Report Key8624152
MDR Text Key145748436
Report Number3004209178-2019-09901
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2014
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2019
Is This a Reprocessed and Reused Single-Use Device? No

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