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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 Premature Elective Replacement Indicator (1483); Pumping Stopped (1503)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) via a manufacturer representative. The stall recovered on its own. The cause of the motor stall was not determined. The pump was refilled on monday ((b)(6) 2018) and was being considered for replacement. The motor stall resolved. No significant symptoms were reported. The patient¿s weight and medical history were not available.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer representative regarding a patient who was receiving hydromorphone (unknown concentration and dose) via an implantable pump. Indication for use was spinal pain. The date of the event was (b)(6) 2018. It was reported the patient began hearing the critical pump alarm last night ((b)(6) 2018). It was confirmed an error code of 8476 (motor stall) occurred on their personal therapy manager (ptm). It was unknown if the patient had magnetic resonance imaging (mri) or if there was any other electromagnetic interference (emi) that caused the stall. No symptoms were reported. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturing representative. A critical alarm occurred upon interrogation. It was unknown when the alarm occurred. The pump will not be returned to the manufacturer.
 
Manufacturer Narrative
Have been updated. The evaluation codes have been updated. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer via the manufacturing representative (rep). It was reported the elective replacement indicator (eri) had occurred early. It was indicated the event occurred on 2018-(b)(6). The pump was alarming and it was reported there were no environmental/external/patient factors that may have led or contributed to the issue. The pump was interrogated and then replaced on 2018-(b)(6). It was indicated the rep had possession of the device and they planned to return the device to the manufacturer for analysis. It was reported the issue had been resolved at the time of the report. The patient's status at the time of the report was provided as "alive - no injury. " other medications being taken at the time of the event, patient weight, and medical history were unknown.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7614466
MDR Text Key112094611
Report Number3004209178-2018-13756
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2014
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/27/2012
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: 06/19/2018 Patient Sequence Number: 1
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