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

Model Number 8637-40

Device Problems Kinked (1339); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994); Chills (2191); Malaise (2359)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 8784, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: catheter.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018,product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: (b)(6) 2017, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a healthcare provider via a company representative regarding a patient receiving dilaudid 10mg/ml at ¿1mg/ml¿ via an implantable pump.The indications for use were non-malignant pain and other chronic/intract pain (trunk/limbs).The patient reported that on (b)(6) 2018 he went in for a normal pump refill.The pa (physician assistant) in the clinic did the pump refill and noted that 12cc was aspirated from the pump reservoir when only 1cc was expected.On (b)(6) 2018 a dye study was performed and the physician reported a visible kink in the catheter with the dye study.The company representative was not notified or present for the dye study.The patient stated that a day after the dye study, (b)(6) 2018 he was experiencing flu-like symptoms including diarrhea, nausea, chills and increased pain.The patient stated he felt better on (b)(6) 2018 as the symptoms started to lesson.On (b)(6) 2018 the catheter was replaced.At the catheter replacement the company representative confirmed with the healthcare provider the patient¿s account of events.The healthcare provider stated that he did not believe that anything was wrong with the pump.The healthcare provider strongly believed that there was a kink in the catheter from the dye study that was resulting in higher than expected reservoir volume during the last pump refill.The healthcare provider only wanted to replace the catheter and was advised to continue to monitor aspiration volumes during pump refills moving forward to make sure the volumes return to expected amounts.It was unknown if the issue was resolved at the time of the report.The patient status was noted as alive, no injury and no further complications were reported.

Manufacturer Narrative

Analysis of the 8780 catheter revealed catheter body kink observed.Analysis of the 8784 catheter revealed catheter body damage to the transition tube.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
• 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: 7398602
• MDR Text Key: 104407311
• Report Number: 3004209178-2018-06506
• Device Sequence Number: 1
• Product Code: LKK
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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): Required Intervention
• Patient Age: 61 YR