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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 Migration or Expulsion of Device (1395); Component Missing (2306); Obstruction of Flow (2423); Insufficient Information (3190); Material Split, Cut or Torn (4008)
Patient Problems Headache (1880); Pain (1994); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544)
Event Date 11/13/2017
Event Type  malfunction  
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 morphine at an unknown concentration and dose via an implantable infusion pump.The indication for use was spinal pain and chronic low back pain.It was reported that the patient had not received and information about the pump including an identification card.The caller stated that the patient was experiencing excruciating pain in their spine.It was noted that the healthcare provider (hcp) offered to schedule a computerized tomography scan of the patient's stomach.It was also reported that the patient was "short and tiny" and since the implant whenever she would sit down the pump would hit her hips and ribs and flip over.No further complications have been reported as a result of this event.
 
Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2019-july-11, additional information was received from the healthcare professional (hcp).Information received the patient being on life support and having a mass in her armpit was a "patient issue".The circumstances that led to the issues was "unknown".The issue occurring with the catheter was clarified to be a kink.The cause of the pump flipping was because "patient broke stitches".
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 15-mar-2019 from the patient who reported that she was still in pain and she mentioned she was getting migraines as well.These were ongoing issues.Her hcp (healthcare professional) did a sideport and pulled back spinal fluid.The patient was seeing a neurosurgeon soon and wanted a company representative to be there.No further complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer indicated that her pain was making it difficult to walk or stand for long periods of time.No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Continuation of concomitant medical products: product i: 8780, serial# (b)(4), implanted: (b)(6) 2017 and product type: catheter.Suspect medical device information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 2019-07-14 and udi#: (b)(4).Correction/update: the conclusion code 22 was previously applied in error and has been replaced with 67.The previously applied method code 4114 has been replaced with 4117.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 via a consumer.Three months after implant, the pump would flip.The date of event was described as being february 2018 (month and year known only).It would be flipping over and over, and it would hit the patient¿s hip and then flip again.After this, there was a catheter issue where the physician told the patient that the catheter was not pulling out any drug and therefore not getting to the right location.Due to the catheter issue, the patient had been in pain as she had been without the therapy.In addition, it was mentioned that the patient was on life support for 3 months and had a mass in her armpit that needed to be removed, but the physician would not touch the mass until the pump was working again.The pump was currently administering morphine of unknown concentration at an unknown dose rate.
 
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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 Key8353587
MDR Text Key136625172
Report Number3004209178-2019-03579
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169530126
UDI-Public00643169530126
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,Followup,Followup,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received07/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age55 YR
Patient Weight52
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