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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 Infusion or Flow Problem (2964); Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2017, product type: catheter. Ubd: 15-dec-2018, udi#: (b)(4). 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) regarding a patient receiving an unknown dose and concentration of bupivacaine via an implantable pump for spinal pain. It was reported the doctor performed a side-port aspiration and the catheter did not aspirate. The patient has not had withdrawal symptoms. An x-ray was taken and the catheter tip was difficult to visualize. There were no environmental/external/patient factors that may have led or contributed to the issue. The doctor may have a computerized tomography (ct) scan or a magnetic resonance imaging (mri) performed. It was unknown if the issue had resolved at the time of the report, (b)(6) 2019. The patient's status was provided as alive - no injury. No further complications were reported or anticipated.
 
Manufacturer Narrative
Product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). It was reported that the patient was morbidly obese which made the catheter difficult to see on x-ray. The hcp was planning a lumbar ct scan to assess the catheter tip. The cause of the inability to aspirate was not determined. It was reported that the patient had a surgical consultation to revise the catheter. The event had not been resolved. The pump seemed to be functioning normally. 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 Key9417042
MDR Text Key173230550
Report Number3004209178-2019-23170
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,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2018
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 Received01/15/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/02/2016
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: 12/05/2019 Patient Sequence Number: 1
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