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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 Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
The pump was returned, and analysis low battery reset-undetermined cause. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on (b)(6) 2018 and it was reported that the pump was replaced on (b)(6) 2018. No further complications were reported/anticipated.
 
Manufacturer Narrative
Interrogation of the pump determined it was used to infuse morphine 12. 0 mg/ml; 0. 074 mg/day and fentanyl 11. 5 mg/ml; 0. 071 mg/day. H3: analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a company representative regarding a patient receiving an unknown drug, dose and concentration not reported via an implantable pump. The indications for use were failed back surgery syndrome and spinal pain. A non-critical alarm occurred, eri (elective replacement indicator). Per the reporter at the pump refill in late (b)(6) 2017, it said 7 months to eri (elective replacement indicator). The healthcare provider checked the pump yesterday, (b)(6) 2018 and it said eri (elective replacement indicator) had occurred on (b)(6) 2018. Per the reporter they plan to replace the pump soon. No patient symptoms and 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 Key7181870
MDR Text Key101648524
Report Number3004209178-2018-00614
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2012
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3043-2011 Z-2276-2009

Patient Treatment Data
Date Received: 01/11/2018 Patient Sequence Number: 1
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