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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Difficult to Advance (2920); Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780 lot/serial# (b)(4), implanted: (b)(6) 2019, product type: catheter, ubd: 16-nov-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturing representative (rep) regarding a patient receiving an unknown medication via an implantable pump for spinal pain.It was reported the rep received a message from the patient that their pump malfunctioned and they were in the hospital.The managing physician stated they tried to do a dye study earlier in the week, relative to (b)(6) 2020, but they were unable to get csf (cerebrospinal fluid) flow black.The patient was being referred to a surgeon.The physician did not know anything about the pump malfunction or the patient being in the hospital.It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.It was unknown if there were any diagnostics/troubleshooting performed.It was unknown if there were any actions or interventions taken to resolve the issue.It was unknown if the issue was resolved at the time of the report, (b)(6) 2020.It was indicated the patient's healthcare provider was not aware of the pump malfunction or hospitalization.The patient's status was provided as alive - no injury.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer who reported that the pump put 2 days of medicine into his body.The patient also stated they have multiple problems, not only he has back problems but his neck and shoulders are killing him.The patient stated they cannot take it anymore, refuses to live with this pain, "this thing is bringing me down even more".The patient stated that this is too negative on his life and they need to stop doing what they are doing.The patient didn't think the healthcare provider was realizing it.The patient also thinks the surgeon put in the wrong pump and something was definitely wrong.The patient wanted to know what was wrong with his pump and whether the pump needed to be explanted.The patient had an appointment tomorrow and would test the pump to see what was wrong with it.The pump was used to deliver dilaudid 1.0mg/ml, bupivacaine 0.05mg/ml and baclofen 400mcg/ml, doses not reported.No further complications were reported regarding the event.

Manufacturer Narrative

Continuation of d11: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: (b)(6) 2020 product type catheter product id 8780 lot# serial# (b)(6) 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.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 from an hcp via a manufacturer representative on (b)(6) 2020.It was reported that there was no device issue with the new catheter that the hcp was unable to implant.The surgeon attempted to gain access by using the needle provided in the kit and made multiple attempts, but was unable to get cerebrospinal fluid (csf).The hcp did not feel comfortable inserting the catheter without getting any csf, so the catheter was discarded.

Event Description

Additional information was received on 27-apr-2020 and it was reported that the patient had an issue with their catheter in the past and the managing physician was unable to get csf (cerebral spinal fluid) when the cap (catheter access port) was conducted.The patient was scheduled for a catheter revision/replacement.During the procedure the surgeon attempted to implant a new catheter but was unable to access the intrathecal space.Multiple attempts were made to gain access to the intrathecal space, and they were unsuccessful.The patient¿s infusion system was explanted and would be replaced at a later date.The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.The patient status was noted as alive, no injury and no further complications were reported regarding the event.

Manufacturer Narrative

Continuation of d11: product id 8780 lot# serial# (b)(6), implanted: (b)(6) 2019, explanted: (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.

• 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: 9644305
• MDR Text Key: 185672896
• Report Number: 3004209178-2020-02139
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention