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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 8637-20
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2018
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 the healthcare provider (hcp) indicated the cause of the premature elective replacement indicator (eri) was not determined. It was noted they would be replacing the reservoir since they did not know what else to do. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal unknown morphine 35 mg/ml at 13 mg/day via an implanted pump for non-malignant pain. It was reported the patient was last seen in (b)(6) 2018 and the elective replacement indicator (eri) showed 28 months. The non-critical alarm occurred over the weekend and showed that eri occurred. This would appear to be a premature eri based on the information. The rep was redirected to follow-up with the healthcare provider (hcp) to review options. Patient symptoms were not reported. The event date was (b)(6) 2018. The rep called back inquiring if he silenced the eri alarm if the pump would still alarm when end of service (eos) occurred. It was reviewed only active alarms could be silenced so they would have to wait until eos occurred to silence the alarm. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the hcp via the rep. It was reported that pump was completely explanted and replaced, was in the possession of the rep, and would be returned to the manufacturer. The issue was resolved. The patient status was 'alive - no injury. Logs indicated the eri alarm occurred 2018-(b)(6). The logs indicated to replace the pump by 2018-(b)(6). No further complications were reported.
 
Manufacturer Narrative
Destructive analysis identified electrochemical migration across the electrical feed-through insulator. Medtronic developed a design change to reduce feed-through shorting and received regulatory approval for the change. Medtronic began distributing pumps with this design change in (b)(6) 2016. 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 Key7868897
MDR Text Key121040451
Report Number3004209178-2018-20443
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 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2015
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2014
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: 09/12/2018 Patient Sequence Number: 1
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