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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 Problems Filling Problem (1233); Increase in Pressure (1491); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who was receiving prialt at an unknown dose and concentration via an implantable pump for non-malignant pain. It was reported that the patient moved to another state and the pump went dry "a couple of weeks ago". It was noted the critical alarm was going off. No symptoms were reported. No further issues were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative. It was reported that the pump was still empty, and considerations were requested.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative on 2019-mar-25. It was reported that the cause of the inability to fill the pump was not determined.
 
Manufacturer Narrative
Analysis of the pump identified a concave outer shield which affected in-vivo use consistent with the damage caused by scuba diving. The previously reported evaluation conclusion, method, and result codes no longer apply. 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 provider via a manufacturer representative on 2019-apr-22. It was reported that the pump was concave during replacement on (b)(6) 2019. It was noted that the patient did scuba dive.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative on 2018-dec-27. It was reported that the patient was waiting for a few new clinics to return their calls to take them on as a new patient. It was unknown whether the empty pump had been resolved.
 
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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
MDR Report Key8159810
MDR Text Key130672691
Report Number3004209178-2018-27547
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/13/2018 Patient Sequence Number: 1
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