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

Model Number 8637-40

Device Problems Kinked (1339); Obstruction of Flow (2423)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. Product id: 8781, serial/lot #: (b)(4), ubd: 11-oct-2019, udi#: (b)(4). 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 hydromorphone 2. 0 mg/ml for a total dose of 0. 4563 mg/day and bupivacaine 30 mg/ml for a total dose of 6. 844 mg/day via an implantable pump for spinal pain. It was reported during a scheduled pump pocket revision on (b)(6) 2018, surgical observation indicated a catheter kink was observed. The catheter was freed from the scar tissue and reattached to the pump. Other surgical intervention included the catheter kink was manually released on (b)(6) 2018. The device diagnosis was catheter kink. The outcome of the event resolved without sequelae on (b)(6) 2018. The etiology of the event indicated 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. No further complications were reported/anticipated.

Manufacturer Narrative

Additional review determined that the previously reported information (pump pocket revision) pertains to manufacturer's report # 3004209178-2018-01757 [pump slanted forward during refill]. Additional information regarding that event will be reported under that manufacturing number. This manufacturing report pertains to the following information: [catheter kink]. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider via a clinical study reported the cause of the catheter kink was not determined. The patient's baseline weight was (b)(6) lbs.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional via clinical study indicated the patient was receiving hydromorphone 2. 0mg/ml for a total dose of 0. 4563mg/day and bupivacaine 30mg/ml for a total dose of 6. 844mg/day. No further complications were reported.

Manufacturer Narrative

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: 7525907
• MDR Text Key: 108640913
• Report Number: 3004209178-2018-11254
• 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: health professional,study

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/18/2018 Patient Sequence Number: 1