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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 Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2017
Event Type  Injury  
Manufacturer Narrative
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.
 
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 via a manufacturer's representative. It was reported that the elective replacement indicator (eri) occurred on (b)(6) 2017 and it was seen when the pump was interrogated on (b)(6) 2017. No motor stall occurred. The cause of the eri is unknown. No diagnostics/troubleshooting was performed. The pump was replaced on (b)(6) 2017. It was reported the issue was resolved at the time of the report. It was reported the patient was receiving 2000mcg/ml gablofen at 739. 7 mcg/day. The patient status at the time of the report was noted as "alive-no injury. " no further complications were anticipated/reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the manufacturers representative indicated that the managing physician was going to send patient to the surgeon for replacement as soon as possible. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care professional via a manufacturers representative regarding a patient who was receiving gablofen (unknown dose and concentration) via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease. The event date was unknown. An alarm was heard and confirmed by telemetry to be a non critical alarm due to elective replacement indicator (eri) the eri alarm was not expected, the last time the pump was interrogated, it had shown 40 months until eri therefore the alarm was unexpected. There were no symptoms reported. No further complications were reported.
 
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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 Key6982797
MDR Text Key102631195
Report Number3004209178-2017-22615
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,Followup
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2014
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: 10/27/2017 Patient Sequence Number: 1
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