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

Model Number 8637-40

Device Problems Failure to Deliver (2338); Insufficient Information (3190)

Patient Problems Therapeutic Response, Decreased (2271); Underdose (2542)

Event Date 07/04/2018

Event Type  Injury  

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6)2018, 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 device manufacturer representative regarding a patient receiving gablofen (1000 mcg/ml, 380 mcg/day) via an implantable infusion pump. It was reported that the patient showed up to the emergency room in baclofen withdrawal. There was not any environmental/external/patient factors that may have led or contributed to the issue. Side port aspiration was performed but the hcp decided that either the catheter or pump was not working and thus both were replaced. The hcp did a prepontine catheter placement with the new catheter and was connected to ascenda catheter using a shunt. The connection was made by using a collet connector from an 8785 kit and peeling away the plastic and only using the pin. He also used a plating system to fasten the shunt distal segment to the head. The issue was resolved and patient status was alive with no injury at the time of the report. No further complication was reported.

Manufacturer Narrative

Evaluation of the pump and catheter showed no significant anomalies. 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

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

Manufacturer Narrative

Continuation of concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter; product id: 8578, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter; product id: 8709, serial# (b)(4), implanted: (b)(6) 2004, explanted: (b)(6) 2018, product type: catheter; section 'device' information references the main component of the system. Other relevant device(s) are: product id: 8578, serial/lot #: (b)(4), ubd: 31-mar-2018, udi#: (b)(4), product id: 8709, serial/lot #: (b)(4), ubd: 28-jun-2006, udi#: (b)(4). New coding applies to pump(8637-40) and catheters(8578, 8709). If information is provided in the future, a supplemental report will be issued.

Event Description

The pump was received with no documentation. The indication of use was intractable spasticity and cerebral palsy.

• 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: 7680548
• MDR Text Key: 113740700
• Report Number: 3004209178-2018-15532
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• 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?: Yes
• Date Device Manufactured: 07/28/2016
• 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: 07/12/2018 Patient Sequence Number: 1