MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Particulates (1451); Insufficient Flow or Under Infusion (2182); Human-Device Interface Problem (2949); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problems Fever (1858); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8711, lot#: j11390r25, implanted: (b)(6) 2002, product type: catheter.Other relevant device(s) are: product id: 8711, serial/lot #: (b)(4), ubd: 29-oct-2004, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2020, information was received from a manufacturer representative (rep) regarding a patient receiving baclofen (2,000 mcg/ ml, 162 mcg/day) via an implantable pump for intractable spasticity.It was reported the on the patient's last refill, there was a volume discrepancy (date unknown).On (b)(6) 2020, a dye study was performed.They were able to aspirate, but did not get clear fluid.The liquid they withdrew was cloudy and pus-like.The rep stated they were able to put the dye in, but could not put all of the dye in.When they looked at imaging, no dye was seen leaving the catheter.The rep stated the healthcare professional (hcp) wanted to do a catheter revision, but they were worried that the patient had a sacral infection and urinary tract infection (uti) (confirmed unrelated to the pump, patient was on antibiotics for it so surgery may not happen until both are cleared).The rep stated they were going to test the cerebrospinal fluid (csf) to see if there were any issues as well.The rep stated they would follow up with the hcp for next steps.The patient's symptoms included fever.

Manufacturer Narrative

Product id: 8711, lot# j11390r25, implanted: (b)(6) 2002, product type: catheter.Update/correction: the previously applied device codes (b)(4) are no longer applicable.The previously applied method code remains applicable to the catheter, and the method code pertains to the pump.The results code was previously coded in error.The results code and conclusion code are applicable to the pump and catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received a company representative.Regarding the volume discrepancy, the estimated residual was 13.8 and the actual residual was 18.The cause of the cloudy fluid withdrawn was determined to be serous fluid from the pump pocket.The cause of not having been able to put all the dye in was due to the physician not having been in the catheter access port during the procedure.The pump was explanted.The serous fluid had been sent for culture.If the culture comes back clean, then the pump will be replaced within one week.If the cultures come back positive, the physician would wait until resolved to replace the pump.The device was being returned to the manufacturer for analysis.The information provided was noted as having been confirmed with the physician/account.

Manufacturer Narrative

Continuation of d11: product id: 8711; lot# :j11390r25; implanted: on (b)(6) 2002; explanted: on (b)(6) 2020; product type: catheter.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.

Event Description

On 2020-may-15, additional information was received from the manufacturer representative (rep).The rep reported they initially hea rd about the event from an healthcare professional (hcp).The catheter was also explanted.The date of explant was on (b)(6) 2020.The cause of the volume discrepancy was not determined.The cause / circumstances that led to the serous fluid in the pocket and hcp not having been in the cap at the time of the dye study was not known.The "interventional radiology doctor felt confident on 2 different occasions that he was in the cap".The results of the culture were not available.Replacement has not been scheduled.

Event Description

Additional information was received from a healthcare provider via company representative.The pump administered compounded baclofen.The device was not yet replaced.The pump and catheter components were returned to the manufacturer.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_cath lot# serial# unknown implanted: explanted: (b)(6) 2020, product type catheter product id 8711 lot# j11390r25 serial# implanted: (b)(6) 2002, explanted: (b)(6) 2020 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: unknown catheter, serial/lot #: unknown, ubd: unknown, udi#: unknown; product id: 8711, serial/lot #: j11390r25, ubd: (b)(6) 2004, udi#: (b)(4), h3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.The returned pump was interrogated and as per the logs baclofen with concentration 1 ,600.0 mcg/ml was being administered at a dose rate of 166.2 mcg/day as of (b)(6) 2020.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.

Manufacturer Narrative

H3: the pump was returned, and analysis found no anomaly.H3: the catheter (lot #: j11390r25) was returned, and analysis found a dark residue occlusion in dispensing hole of the catheter body that was event related.H3: an unknown catheter (unknown serial number) was returned, and analysis found no significant anomaly (coring-tears-cuts in the seal of the sc connector and no leak was seen in lab and there was no leak allegation.H6: all previously reported method, result, and conclusion codes no longer apply to this event.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.

• 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 Key: 10045355
• MDR Text Key: 190572464
• Report Number: 3004209178-2020-08422
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 05/12/2020; 05/15/2020; 05/12/2020; 06/08/2020
• Supplement Dates FDA Received: 05/14/2020; 05/19/2020; 05/22/2020; 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention