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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and healthcare provider via a company representative regarding a patient who was receiving fentanyl with concentration 4000 mcg at a dose rate of 24 mcg via an implantable pump for non-malignant pain.It was reported that the patient experienced withdrawal symptoms.There were no known environmental/external/patient factors that may have led or contributed to the issue.The event occurred during normal use.Regarding diagnostics / troubleshooting performed including results and dates, it was indicated as none were known.Surgical intervention occurred.A surgeon tried to aspirate at the pump segment and connector of the spinal and pump segment.The catheter was revised.As per the manufacturer¿s device registry, the catheter was explanted and replaced on (b)(6) 2018.The issue was noted as having been resolved.No further patient complications have been reported as a result of this event.The patient was without injury regarding their status at the time of the report.Other medications the patient was taking at the time of the event was not available and unable to be obtained.The patient¿s medical history and weight were indicated as having been asked but were unknown.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider via the manufacturing representative (rep).The rep was unaware of when the patient first started experiencing withdrawal symptoms, and indicated they first learned of the issue in pre-op.It was reported the surgeon indicated the catheter was occluded at both sites (referring to both the pump segment, and connector of the spinal and pump segment).The catheter was in the possession of the rep, and it was indicated it would be returned for analysis.

Manufacturer Narrative

Continuation: product id: 8780, serial# : (b)(4), implanted: (b)(6) 2015 explanted: (b)(6) 2018, product type catheter section d information references the main component of the system and other applicable components are: product id: 8780, serial#: (b)(4) ,ubd: 2017-10-01, udi#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018 , product type catheter.The complete catheter was returned to the manufacturer in two segments.Analysis of the catheter on 2018-apr-17 revealed a user related kink in the catheter body of the distal/spinal catheter segment.Analysis also revealed damage to the transition tubing of the catheter body.The results code (b)(4) and conclusion code (b)(4) pertains to the analysis finding of kink in the catheter body.The results code (b)(4) and conclusion code (b)(4) refers to the analysis finding of damaged transition tubing of the catheter body.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: 7295294
• MDR Text Key: 100890175
• Report Number: 3004209178-2018-03915
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2018

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: 04/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 02/25/2018
• Supplement Dates Manufacturer Received: 02/26/2018; 04/17/2018
• Supplement Dates FDA Received: 02/26/2018; 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2015
• 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: 51 YR