Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Patient Problems Headache (1880); Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517)
Event Date 01/06/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a manufacturer representative on (b)(6) 2020.It was reported that the catheter was initially placed in the skull on purpose but the patient did not respond well to the placement because of headaches, so it was moved back to itb.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 29-aug-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer representative (rep) regarding a patient receiving unknown baclofen 2250 mcg/ml for a total dose of 274 mcg/day and later noted receiving gablofen 2000 mcg/ml for a total dose of 99.9 mcg/day via an implantable pump.It was reported they were doing a catheter revision (replacing the whole catheter) on (b)(6) 2020 and needed assistance with programming.It was noted they will be decreasing the concentration and the pump would be on the back table and they inquired how to do it.The procedure was reviewed.The event date was (b)(6) 2020.The symptoms the patient experienced included headaches and escalating doses with no improvement in symptoms.It was noted that the cause of the issue was the catheter was placed in the dural space (idb) in the skull and the catheter was moved to the intrathecal space (itb).It was noted the size of the catheter was unknown and the catheter was disposed.It was noted there was no factors that may have contributed or led to the event.No diagnostics were performed.Surgical intervention occurred where the catheter was just swapped out for a new one.It was noted the catheter would not be shipped back.It was noted that everything had been resolved.The patient's status was alive-no injury.No further complications were reported.
 
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 received from a healthcare professional (hcp) via a clinical study reported medication was administered on (b)(6) 2020.It was noted that because the symptoms developed following the catheter placement and an intrathecal catheter was previously tolerated, the symptoms were believed to be related to the intra ventricular placement of the catheter.No further complications were reported.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study reported on (b)(6) 2020 following i-v (intravenous) catheter placement, the patient suffered from severe insomnia that has not resolved with time or interventions.The insomnia was thought to be related to the placement of the catheter and related to catheter repositioning that took place as an action on (b)(6) 2020.Medication was administered on (b)(6) 2020.It was noted that the catheter placement issue resolved without sequelae on (b)(6) 2020.The clinical diagnosis was insomnia.It was noted that the event required in-patient or prolonged hospitalization.The event resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.The etiology of the event indicated the relationship of the event to the device or therapy was possibly related and indicated the relationship of the event to the implant procedure was not related.No further complications were reported.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9795008
MDR Text Key183427986
Report Number3004209178-2020-04759
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169630512
UDI-Public00643169630512
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,health
Type of Report Initial,Followup,Followup,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/28/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received05/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
"SEE H10...."
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age18 YR
-
-