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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 Device Or Device Fragments Location Unknown (2590); Material Integrity Problem (2978)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Continuation of medical devices: product id 8731, serial# (b)(4), implanted: (b)(6) 2004, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8731, serial/lot #: (b)(4), ubd: 04-mar-2006, 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) regarding a patient receiving an unknown intrathecal medication via an implanted pump for spinal pain.It was noted this was a fairly new patient of theirs, so she did not have much information about this event.The patient had told them he could not have a mri because he had a little piece of catheter that had broken off and was now at the bottom of his spine.The hcp wanted to know mri guidelines for the catheter and if what the patient said was true.It was reviewed mri guidelines did not address the catheter and there would be no anticipated issue with it.The reporter was to follow up the doctor.Patient symptoms were not reported.The event date was asked and unknown.No further complications were reported/anticipated or expected.
 
Event Description
Additional information was received that reported the catheter revision surgery was done on (b)(6) 2020.The physician revised the spinal segment of the existing catheter with a new catheter.There was good csf (cerebral spinal fluid) flow throughout the case.Good connection and the pump was programmed and updated per the physician.Additional information was received on 24-aug-2020 that reported that the patient was discharged from the hospital following catheter revision recovering well.No further complications were reported regarding the event.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer and healthcare provider (hcp) via the manufacturing representative (rep).It was reported that per the physician's office, the catheter was sheered at t12/l1.It was noted this occurred during normal use.The original catheter was older, it was from 2004.A dye study had been performed to diagnose the catheter issue.The catheter will be replaced on 2020-(b)(6).Therefore, the issue was unresolved at the time of the report, 2020(b)(6).
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, 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 Key7583978
MDR Text Key110586427
Report Number3004209178-2018-13016
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100831
UDI-Public00643169100831
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
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/14/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received08/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
"SEE H10...."
Patient Outcome(s) Required Intervention;
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