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

Model Number 8637-40

Device Problems Device Or Device Fragments Location Unknown (2590); Material Integrity Problem (2978)

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

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, lot# n283304012, implanted: (b)(6) 2011, explanted: 2018, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: n283304012.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving baclofen 2000 mcg/ ml; 730 mcg per day before revision, 350mcg/ml after revision via an implantable pump.Indication for use was cerebral palsy and intractable spasticity.The date of the event was (b)(6) 2018.It was reported that during a pump replacement the catheter was found to be severed in the pocket behind the pump.The physician was certain that it was not cut during procedure.There was no complaint regarding the pump.A catheter revision was done with a partial explant of the catheter.The physician was unable to access the remainder of the catheter so it was left implanted but out of service.The pump and catheter were replaced (b)(6) 2018 and will be returned to the manufacturer.No environmental/external/patient factors may have led or contributed to the issue.No diagnostics/troubleshooting were performed.The issue was resolved.Patient status was alive - no injury.Patient weight was asked but unknown.Patient medical history was cerebral palsy.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative.The cause of the cut catheter was not determined.No symptoms were reported by physician or family.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, lot# n283304012, implanted: (b)(6) 2011 explanted: (b)(6) 2018, product type: catheter; udi#:(b)(4).The pump was returned, and analysis found gear train anomaly; corrosion and-or wear and-or lubrication and stall due to shaft-bearing.The catheter was returned, and analysis found the catheter body was broken.Per pump telemetry the pump was delivering lioresal 2000 mcg/ ml; 730 mcg per day.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): 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: 7625570
• MDR Text Key: 111890566
• Report Number: 3004209178-2018-14001
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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?: Yes
• Date Returned to Manufacturer: 06/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2011
• 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: 22 YR