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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 Detachment of Device or Device Component (2907)
Patient Problems Overdose (1988); Loss of consciousness (2418)
Event Date 09/01/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 10-apr-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient who was receiving 100 mcg/ml baclofen at 50 mcg/day, and 10 mg/ml dilaudid at 5 mg/day via an implantable infusion pump for spinal pain. It was reported that the catheter tip had detached, and the patient had to have a catheter revision done. There were no symptoms from the catheter tip detaching. However, after the catheter revision the patient was not waking up despite being treated with narcan. The patient was intubated. The patient was in the intensive care unit (icu), but as of (b)(6) 2019 the patient had been awake and was doing fine. No further complications were reported.
 
Manufacturer Narrative
Product id 8780, serial# (b)(4), product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative (rep). It was reported that the cause of the unresponsiveness was not determined. The healthcare professional didn't think it was the pump because the patient had a lot of health issues. 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 Key9172011
MDR Text Key161711737
Report Number3004209178-2019-19273
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2019
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 Received10/09/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/20/2018
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: 10/09/2019 Patient Sequence Number: 1
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