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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 01/01/2018
Event Type  Injury  
Manufacturer Narrative
The pump was returned, and analysis found pump motor feedthru anomaly, shorting across insulator. Method code (b)(4) and conclusion code (b)(4) are no longer applicable to the event. Recent fda coding changes offer limited options for medical device evaluation conclusion coding. Medtronic selected conclusion code (b)(4) because, although the device meets design specification, corrective actions are focused on enhancements to the design making this the closest code available with respect to this event. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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
Additional information received reported that the patient was scheduled for a pump replacement next week. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported pump replacement was scheduled for 2018 (b)(6). It was indicated the event was related to the device or therapy. No outcome was noted.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the patient was seen for pump refill on (b)(6) 2017 with an estimated eri of 47 months. The patient returned, on (b)(6) 2018, for a pump refill and upon interrogation it was noted that eri had occurred on (b)(6) 2018. The pump was explanted and replaced on (b)(6) 2018. It was noted the device was returned to the manufacture. The issue resolved without sequelae on (b)(6) 2018.
 
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 clonidine 100mcg/ml at 54. 50mcg/ml and baclofen 750mcg/ml at 408. 75mcg/day via an implantable pump. The indication for use was intractable spasticity. It was reported that an alarm was heard and confirmed by telemetry. The alarm was due to eri (elective replacement indicator). Per the reporter the patient was last seen for a refill on (b)(6) 2017 and the eri (elective replacement indicator) was 47 months. Eri (elective replacement indicator) occurred on (b)(6) 2018. Per the reporter the eri alarm was unexpected. The reporter planned to discuss options with the healthcare provider. 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)
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 Key7178800
MDR Text Key103217282
Report Number3004209178-2018-00539
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 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2014
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: 01/10/2018 Patient Sequence Number: 1
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