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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 Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problems Discomfort (2330); Sleep Dysfunction (2517)
Event Date 02/27/2015
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 regarding a patient receiving dilaudid (20mg/ml at min rate) via intrathecal infusion pump for spinal pain.It was reported the patient¿s pump was implanted in their buttocks and it wasn't comfortable when they drive or sleep meaning they couldn't sleep at night and had problems driving.It was reported the patient was working with the hcp to plan a revision to move the pump to their stomach.It was noted the pump had ¿died¿ before and since the pump was nearing eos the patient requested to change the pump at the same time "to ensure the pump doesn't die again".It was reported the patient¿s insurance denied their claim.The patient was redirected to the hcp and their insurance to discuss further.Omitted information regarding the pump having ¿died¿ before.See (b)(4) for more info.
 
Event Description
Additional information was received from the healthcare provider indicated that the pocket would be moved to the patients stomach on (b)(6) 2020.
 
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.
 
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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 Key10636524
MDR Text Key210373521
Report Number3004209178-2020-17337
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 consumer,health professional
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received10/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient Weight70
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