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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 Kinked (1339); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); Protective Measures Problem (3015)
Patient Problem Muscular Rigidity (1968)
Event Date 05/18/2018
Event Type  Injury  
Manufacturer Narrative
Continuation of medical devices: product id neu_unknown_cath, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_cath.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare provider (hcp) via a clinical study regarding a patient who was receiving baclofen via an implantable pump for an unknown indication for use.It was reported the patient reported complaints of increasing spasticity "since a disadvantage." they stated the last week was very bad.The pump was refilled with 40 cc of intrathecal baclofen.The estimated volume was 3 ml, and the real volume was 25 ml.This device interrogation revealing "to much rest volume" occurred on (b)(6) 2018.Because of this abnormally high volume, in combination with increased spasticity, a catheter study was planned.It was stated a pump study was carried out on (b)(6) 2018.A rotor study showed the pump was working.A ct scan/catheter course without contrast was performed.It was stated there was difficult catheter visualization.There was the presumption (but with reservation) of possible bending in the catheter.It was reported "posting sideport" did not succeed.It was also reported the itb pump was deep in the subcutaneous tissue.The provided device diagnosis was catheter kink.The event was related to the device/therapy, and unlikely related to the implant procedure.No further complications were reported.
 
Manufacturer Narrative
The main component of the system.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 2018-12-12, (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received on 2018-jun-19 indicated that the event was not related to the implant procedure.
 
Manufacturer Narrative
Concomitant medical products: product id: 8781, lot# 0212537483, implanted: (b)(6) 2017, product type: catheter if information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received.The patient's pump and catheter were implanted on (b)(6) 2017.The lot number of the catheter was provided.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The manufacturer's representative provided the tracking number for the catheter return.The clinical site uploaded in-vivo catheter imaging.Review of the imaging did not reveal any apparent anomalies.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The lot number of the catheter was again updated by the clinical site, this time to (b)(4).Additional information was received from the clinical site 3 days later; they updated the lot number of the catheter again, this time to (b)(4).Clarification for the correct lot number has been requested.
 
Manufacturer Narrative
Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received.A revision of the spinal catheter was performed on 2018-(b)(6).The event resulted in in-patient hospitalization.There was confirmation of a kink in the catheter.A new spinal catheter (with revision kit) was placed.The catheter was provided to a manufacturer's representative.The event resolved without sequelae on 2018 (b)(6).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received.The patient was receiving baclofen (500.0 mcg/ml at 165.16 mcg/day).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received indicated that the catheter side port aspiration was done on (b)(6) 2018 and aspiration was not possible and there was "probably catheter dysfunction.".
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received.The outcome of the event was updated to resolved without sequelae on 2018-jun-06.The lot number of the catheter was updated to 0212537483p, then was updated to 0213673794.Additional information was received.The clinical site also indicated that surgical revision was performed and no kink was found.They stated the cause of the potential kink was not identified.It was stated the catheter was explanted and replaced on (b)(6) 2018.The site indicated it was unknown if the catheter would be returned.Additional information was received.The lot number of the catheter was again updated to 0212537483p.The date of the catheter revision was updated to (b)(6) 2018.Follow-up is being performed to confirm the correct catheter lot number, date of revision, date of outcome, and whether kink was confirmed.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The lot number of the catheter was again updated by the clinical site, this time to (b)(4).A response from the site has not yet been received regarding the correct catheter lot number.The clinical site confirmed that there was confirmation of a kink in the catheter.The revision was performed on (b)(6) 2018.A package was received at the (b)(6), including a packing slip with the reference number of this product event, (b)(4), on it.The package included a pump, serial number (b)(4), and an unknown device.The returned pump serial number does not match the provided serial number of the pump involved in this event.Also, there had been no report of a pump explant, so pump return was not expected.Additionally, review of the returned pump initial interrogation indicated the elective replacement indicator (eri) was 2 months, however, the reported implant date of the pump involved in this event was (b)(6) 2017.Clarification has been requested.
 
Manufacturer Narrative
A portion of the proximal segment of the catheter was returned.Analysis identified a user-related kink of the catheter body.Fdm updated.Fdr updated.Fdc updated.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received.The lot number of the catheter was again updated by the clinical site, this time to 0212537483.
 
Event Description
Additional information was received from the clinical site.It was confirmed that pump (b)(6) was the correct serial number of the patient's pump, but then it was stated that the pump had been explanted and returned.It is assumed that the explant and return was describing pump (b)(6), which was returned along with this associated product event reference number.If pump (b)(6) is received, a supplemental report will be submitted.A new product event will be created for the returned pump.Images of the returned products were provided by the product analysis team.The images indicated a pump ((b)(6)) was returned with a section of the proximal pump segment, including the sutureless connector, still attached.Additionally, a different section of catheter, including the sutureless connector, was returned.Additional information was received from the clinical site.The lot number of the associated catheter was again updated, this time to 0212537483p.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the clinical site.The date the event resolved without sequelae was updated to 2018-jul-04.Additional information was received from the manufacturer's representative.They stated that "there was also a pump in the package b ut with the pump was nothing wrong.The pump works well!" the clinical site would be contacted to investigate whether the returned pump was part of this event.
 
Manufacturer Narrative
Analysis of the returned catheter has not yet been completed as of the date of this report.A follow-up report will be submitted when analysis is complete.Fdm updated to 4118.Fdr updated to 3233.Fdc updated to 11.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 Key7579981
MDR Text Key110458632
Report Number3004209178-2018-12906
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2018
Date Manufacturer Received01/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age53 YR
Patient Weight71
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