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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 Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving baclofen of an unknown concentration at an unknown dose rate via an implantable pump.It was reported that the implanted pump started giving the acoustic critical alarm and the patient contacted the physician for advice at once.The physician interrogated the pump and received a message that the pump was in safe mode due to unknown reasons.The date of the event was unknown.Reg arding environmental/external/patient factors that may have led or contributed to the issue, it was noted that the patient was flying by plane and therefore may have passing the security scanners at the airports.The physician was able to reprogram the pump without a problem and the pump was working fine since then.The issue was resolved.The patient was to see the physician in (b)(6) 2023 for an additional refill.It was agreed that the physician will obtain the log files from the pump to see if the date of the error and the patient taking flights match up.The physician will also ask if the patient used the normal security scanners.The physician was advised to contact medtronic as soon as possible if the patient experienced any other issues with the pump.The patient was without injury regarding their status as of (b)(6) 2023 no surgical intervention occurred and no surgical intervention was planned.The patient's medical history, gender, age, and weight at the time of the event was unknown or would not be made available.
 
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.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
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 foreign healthcare provider via a company representative.It was reported the pump entered safe mode on (b)(6) 2023 for unknown reasons.According to the doctor, the patient was not aware of any external factors that could have caused the error.There were no security scanners involved at all.After reprogramming, the pump was working as intended since then.The exact implant date is unknown however the physician mentioned in may and the time to eos was 53 months according to the clinician programmer.The doctor was using an old nvision clinician programmer, so there are no digital log files available.
 
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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
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key16929951
MDR Text Key315210391
Report Number3004209178-2023-06427
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/14/2022
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/11/2023
Date Device Manufactured10/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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