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 Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); Device Embedded In Tissue or Plaque (3165)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, lot# n301380014, implanted: (b)(6) 2011, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8709sc, serial/lot #: n301380014, ubd: 16-aug-2013, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and healthcare professional (hcp) via a company representative regarding a patient receiving compounded baclofen (2000 mcg/ml at 786 mcg/day in simple continuous mode) via an implanted pump.The indication for pump use was head/brain injury and intractable spasticity.On (b)(6) 2018 it was reported that the patient started showing signs of baclofen withdrawal the morning of (b)(6) 2018.The patient was seen and discharged.The patient came back in the very early hours of (b)(6) 2018 with worsening symptoms of withdrawal.The pump was interrogated and there were no errors detected in programming.At roughly 3 am on (b)(6) 2018, a catheter replacement surgery was performed.There was no flow when aspirating the catheter.The surgeon then checked the spinal segment of the catheter and found that the catheter was restricted/had blockage near the anchor site to where the drug/csf (cerebrospinal fluid) could not flow properly.The patient was not receiving baclofen.The surgeon removed most of the existing catheter but could not remove the spinal segment/tip in the intrathecal space.A new catheter was implanted.The issue was resolved at the time of this report.The patient status was reported as ¿alive ¿ no injury¿.It was indicated that the hcp did not have any further information regarding the event.With regards to any environmental, external or patient factors that may have led or contributed to the issue, ¿na¿ was noted.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: 7450282
• MDR Text Key: 106150679
• Report Number: 3004209178-2018-08561
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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
• Report Date: 04/23/2018

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: 07/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 04/23/2018
• Date Device Manufactured: 01/31/2018
• 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: 24 YR