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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 Pumping Stopped (1503); Human-Device Interface Problem (2949)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer representative regarding a patient who was receiving compounded baclofen via an implantable pump for intractable spasticity and cerebral palsy.It was reported that the patient's pump was alarming with a motor stall of the pump.The logs were downloaded and multiple motor stalls were shown.A pump replacement will be scheduled as soon as possible.The issue was not resolved at the time of the report.The patient weighed (b)(6) and their medical history was asked but unknown.The patient was without injury at the time of the report.
 
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 patient who reported that she was hearing a sound, but was not sure where it was coming from until saturday ((b)(6) 2021) night when they determined it was the pump alarming.She stated that she heard the sound on tuesday ((b)(6) 2021) but was not aware it was the pump.Then when the pump was interrogated at the doctor¿s office on sunday ((b)(6) 2021) afternoon she was told that the pump showed it started alarming on tuesday of last week after which she stated that she didn¿t hear it on tuesday.She stated that she was told that her pump was alarming due to intermittent motor stalls and it was explained to her that the pump motor was stopping and then restarting again and they were not sure when the pump would permanently stop and were recommending replacement as soon as possible.Per the patient, the pump was delivering baclofen (575 mcg/ml at 137.74 mcg/day).
 
Manufacturer Narrative
H3: analysis of the pump revealed pump motor feed thru anomaly; shorting across insulator.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.
 
Manufacturer Narrative
H3 ¿ analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Interrogation of the pump upon receipt indicated the brand of the baclofen was lioresal.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 a company representative indicating that the pump was replaced.
 
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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 Key12160206
MDR Text Key261288089
Report Number3004209178-2021-10764
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
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
Remedial Action Notification
Type of Report Initial,Followup,Followup,Followup
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2021
Initial Date Manufacturer Received 07/10/2021
Initial Date FDA Received07/13/2021
Supplement Dates Manufacturer Received07/11/2021
07/19/2021
09/29/2021
Supplement Dates FDA Received07/15/2021
08/05/2021
09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1579-2013
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient Weight75
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