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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Aspiration Issue (2883); Infusion or Flow Problem (2964)

Patient Problems Scar Tissue (2060); No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# : (b)(4), implanted: (b)(6) 2011, product type: catheter.Product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 23-aug-2013, udi#: (b)(4); product id: 8598a, serial/lot #: (b)(4), ubd: 19-nov-2012, 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 via a company representative regarding a patient who was receiving gablofen with concentration 2000 mcg/ml at a dose rate of 591 mcg/day via an implantable pump for intractable spasticity and cerebral palsy.It was reported that a catheter explant and replacement was not planned but was performed.The event occurred during a procedure.Interoperative aspiration of the catheter had revealed an occlusion.It was further noted that catheter aspiration and proximal segment replacement was tried, but patency was not restored.It was noted that the complete catheter had been explanted and was replaced.Environmental/external/patient factors that may have led or contributed to the issue was indicated as being not applicable.The issue was resolved at the time of the report.The patient was without injury regarding their status at the time of the report.Other medications (oral, iv, etc.) the patient was receiving at the time of the report was unable to be obtained.The patient¿s medical history was indicated as having been requested but was unavailable.It was indicated that the hcp was notified that the product should be returned to the manufacturer; however, the hcp had discarded the catheter.No patient symptoms were reported.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

D11 update/correction: product id 8709sc lot# serial# (b)(4) implanted: 2011 (b)(6) explanted: 2018 (b)(6) product type catheter product id 8598a lot# serial# (b)(4) implanted: 2011 (b)(6) explanted: 2018 (b)(6) product type catheter update/correction: the initial report did not include the recall and notification information.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: catheter; product id: 8598a, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: catheter.Updated to reflect the information received on 2019-jan-31.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a clinical study on 2019-jan-31.It was confirmed that the pump was replaced due to normal battery depletion.It was reported that the proximal portion of the catheter was noted to be occluded with scar tissue.After the proximal portion of the catheter was replaced, it was noted that egress of csf remained unobtainable.It was also reported that the patient had a spinal fusion which resulted in a difficult and technically complex replacement of the catheter.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 possibly related.No further complications were reported/anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7630447
• MDR Text Key: 112061704
• Report Number: 3004209178-2018-14148
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• 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: 01/31/2019
• Date Device Manufactured: 09/06/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1575-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 52