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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Overdose (1988); Rash (2033); Respiratory Distress (2045)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

Product id: 8711, serial# (b)(4), implanted: (b)(6) 2001, product type: catheter.Other relevant device(s) are: product id: 8711, serial/lot #: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving fentanyl and clonidine (unknown concentration and dose) via an implantable pump.Indication for use was non-malignant pain.The date of the event was (b)(6) 2018.It was reported the patient experienced an overdose.The patient had a dye study on (b)(6) 2018.It was unknown why the dye study was done.Shortly after the dye study the patient went into respiratory distress and had to be admitted to the intensive care unit (icu).Per the hcp, there may have been a dislodged kink or clot that allowed a bonus to enter the patient but was not sure.The patient is on an extremely high concentration and dose of fentanyl and clonidine and that was likely the cause.The pump was turned to minimum rate, but the patient was still struggling and due to the concentration, the hcp wanted the pump off.The hcp contacted the representative on (b)(6) 2018 to request the password to shut off the pump.The representative instructed the hcp on temporary stop pump procedure as opposed to minimum rate.The hcp planned to explant the pump thursday if the patient stabilizes and follow a different drug regimen.Surgical intervention was scheduled for (b)(6) to explant the pump.Patient weight and medical history were unknown.It was unknown if any environmental/external/patient factors may have led or contributed to the issue.It was unknown if any diagnostics or troubleshooting was performed.The issue was not resolved.Patient status was alive - with injury noted as the patient was currently in the icu per phone call with physician on (b)(6) 2018.No further complications were reported.

Manufacturer Narrative

Per telemetry the pump was delivering clonidine 135.0 mcg/ml, bupivacaine 14,600.0 mcg/ml and fentanyl 20,000.0 mcg/ml (doses unknown).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation: product id neu_ascenda_cath lot# serial# unknown implanted: explanted: product type catheter product id 8711 lot# serial# (b)(4) implanted: 2001-(b)(6) explanted: 2018-(b)(6) product type catheter: the pump was returned, and analysis found no anomaly.The catheters were returned, and analysis found no significant anomaly.The catheter was incomplete and returned in segments.The catheter body had a slice cut.H6:conclusion code 11, method code 4114 and results code 3233 are no longer applicable to the event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation: product id 8711 lot# serial# (b)(4) implanted: 2001-(b)(6) explanted: 2018-(b)(6) product type catheter product id 8711 lot# serial# (b)(4) implanted: 2001-(b)(6) explanted: 2018-(b)(6) product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from healthcare professional (hcp) via the manufacturer representative (rep).It was reported that today per the hcp the patient had an infection at pump site a few days after revision and it was explanted.Pump and catheter were explanted.The devices would not be returned.The rep was not present for explant.No further complications were reported.

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

Product id: 8711, serial# (b)(4), implanted: (b)(6) 2001, explanted: (b)(6) 2018, product type: catheter; product id: neu_ascenda_cath, serial# unknown, product type: catheter; product id: 8711, serial# (b)(4), implanted: (b)(6) 2001, explanted: (b)(6) 2018, product type: catheter.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer on 2019-feb-05.It was reported that the infection was associated with the implant of the patient's pump (note: this conflicts with the previous report that the infection occurred a few days after revision).It was noted that the infection was on the left side of the patient's abdomen, which was the opposite side of the body from the pump.It was further noted that the pump had been leaking for over three years because the patient had a rash on the abdomen for over three years, and as soon as the pump was removed the rash went away.Since explant, the patient's pain was ridiculous without the pump, and the patient was placed on a fentanyl patch to keep him from withdrawals.The patient was reportedly getting "a total of 20,000 of fentanyl.".

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7679551
• MDR Text Key: 113740246
• Report Number: 3004209178-2018-15547
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/07/2019

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: 02/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 08/02/2018; 09/05/2018; 08/08/2018; 08/08/2018; 02/05/2019
• Supplement Dates FDA Received: 07/18/2018; 08/10/2018; 09/06/2018; 10/04/2018; 10/05/2018; 02/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR