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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Premature Elective Replacement Indicator (1483); Intermittent Infusion (2341)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a company representative regarding a patient receiving dilaudid (5 mg/ml at 2. 3991 mg/day) and marcaine (2 mg/ml at 0. 9596 mg/day) via an implanted pump. The indication for pump use was non-malignant pain. On (b)(6) 2017 it was reported that motor stall was seen at initial interrogation. The patient had not recently had an mri. The patient reported he heard the critical alarm going off this past saturday but then it stopped. The patient was hearing the alarm again this morning so the patient came in to have it checked. The pump was currently not alarming. The pump logs were checked and showed a motor stall recovery occurred at 13:07 on (b)(6) 2017 and then a motor stall occurred at 13:19 and recovered at 14:10. The logs went back to (b)(6) 2017 but the reporter was not seeing any motor stall occurred prior to the motor stall recovery that occurred. It was confirmed that there were no emi/magnetic sources present. The patient had no symptoms. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 28-apr-2017 and it was reported that no intervention had been made yet. The doctor decided that if the alarm went off again then the patient would be sent for replacement. The cause for the motor stalls was not determined. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. 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 2017-may-16. It was reported that intermittent motor stalls and recoveries were seen starting on (b)(6) 2017. Pump logs also indicated that early replacement indicator (eri) occurred on (b)(6) 2017. It was confirmed that no mri, electromagnetic interference (emi), or other magnetic interaction occurred. The pump was being replaced on (b)(6) 2017. No patient symptoms were reported.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the patient¿s pump was replaced (b)(6) 2017. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Analysis of the pump identified electrochemical migration across the electrical feed-through insulator which caused an electrical short. The electrical short resulted in multiple motor stalls and al low battery reset. Correction numbers z-2276-2009 and z-3043-2011 no longer apply. 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)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6529141
MDR Text Key102357482
Report Number3004209178-2017-09248
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1579-2013

Patient Treatment Data
Date Received: 04/28/2017 Patient Sequence Number: 1
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