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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 Failure To Service (1563)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was provided by a healthcare provider via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver morphine at a concentration of ¿1¿ at a dose of ¿1¿ and "none," indicated for non-malignant pain. It was reported that the patient moved to (b)(6) and couldn¿t find someone to fill pumps. The event date was reported as (b)(6) 2016. Factors that may have led or contributed to the issue included they were unable to fill the pump and found cbd (cannabidiol) oil working. It was indicated that as part of diagnostics/troubleshooting, the checked with several doctors to fill the pump and were unable. They called multiple places as an intervention/action taken to resolve the issue. It was indicated that the issue was resolved. It was reported that surgical intervention occurred, and the pump was explanted on (b)(6) 2018. The patient¿s status was unknown. No further complications were reported or anticipated. The patient¿s medical history and weight were asked but unknown. Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.
 
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 via a manufacturer's representative on (b)(6) 2018. The patient's status was reported as "alive - no injury. " it was indicated that the device would not be returned, as it was kept by the account. It was stated that there was no issue with the device. The provided information was confirmed with the physician/account. No further complications were reported or anticipated.
 
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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 Key7569626
MDR Text Key110092534
Report Number3004209178-2018-12600
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
Type of Report Initial,Followup
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/12/2014
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: 06/05/2018 Patient Sequence Number: 1
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