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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 Problems Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Overdose (1988); Lethargy (2560)
Event Date 03/28/2018
Event Type  Injury  
Manufacturer Narrative
Event date is approximate. 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 manufacturing representative (rep) on (b)(6) 2018 regarding a patient receiving an unknown dose and concentration of an unknown drug via an implantable pump for spinal pain. It was reported the patient was in the intensive care unit (icu) and was showing signs of overdose following their targeted drug delivery (tdd) system replacement (b)(6) 2018. It was unknown when the symptoms began in relation to the system replacement. It was indicated the nurse would contact the rep the next morning if they wanted the pump adjusted. It was indicated the medical facility had contacted the managing doctor and it was recommended to have the pump turned down to minimum rate mode. The pump was then adjusted and turned down to minimum rate mode by a doctor at the medical center. No further complications 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 via a healthcare provider. The patient was in the hospital and the healthcare provider had wanted someone to come and decrease the daily dose. They believed the patient was getting too much medication. The patient had difficulty breathing, was lethargic, and had experienced hallucinations. The change in symptoms/therapy occurred suddenly. The date of the event was (b)(6) 2018. The patient was currently receiving morphine of unknown concentration at an unknown dose rate.
 
Manufacturer Narrative
Only adverse event was previously indicated in the initial report and the previous report should have included adverse event product problem. 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.
 
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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 Key7383924
MDR Text Key103910079
Report Number3004209178-2018-06062
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 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2019
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 Received05/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1570-2014

Patient Treatment Data
Date Received: 03/29/2018 Patient Sequence Number: 1
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