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

Model Number 8637-40

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; the other relevant: components include: product id: 8781, serial# (b)(4) , implanted: (b)(6) 2015, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient receiving dilaudid 2.0mg/ml for a total dose of 0.9997mg/day and bupivacaine 20.0mg/ml for a total dose of 9.997mg/day via an implantable pump for non-malignant pain and degenerative disc disease/herniated disc pain.It was reported on (b)(6) 2018 during a scheduled pump revision, surgical observation noted a catheter kink at both sides of the connecting pin and anchor was noted.The kinks were removed, a new connecting pin was added, and the tip was pulled down.On (b)(6) 2018, the catheter was repositioned.The outcome of the event resolved without sequelae on (b)(6) 2018,.The etiology of the event in dicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The event date was (b)(6) 2018.The patient's weight was (b)(6) pounds.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial (b)(4), implanted: (b)(6) 2015, product type: catheter, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated the catheter was repositioned on (b)(6) 2018 not on (b)(6) 2018.The surgical observations where the catheter kink was observed was on (b)(6) 2018 not on (b)(6) 2018.No further complications were reported/anticipated.

Manufacturer Narrative

Product id (b)(4) lot# serial# (b)(4) implanted: (b)(4) 2015 explanted: product type catheter udi# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from healthcare provider (hcp) via a clinical study indicated the cause of the catheter kink was not determined.No further complications were reported/anticipated.

• 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: 7230541
• MDR Text Key: 98672127
• Report Number: 3004209178-2018-01725
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• Date Device Manufactured: 08/07/2015
• 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: 61 YR
• Patient Weight: 69