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

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); Protective Measures Problem (3015)

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

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 8780, lot/serial#: (b)(4), implanted: (b)(6) 2013, product type: catheter, ubd: 07-dec-2014, 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 manufacturing representative (rep) regarding a patient receiving an unknown dose and concentration of baclofen via an implantable pump for intractable spasticity and cerebral palsy.It was reported the patient was being weaned because the patient was doing very well and the hcp wanted to see if the patient could come off their infusion therapy.It was thought the patient may no longer need intrathecal baclofen therapy any longer.The patient had a routine catheter port aspiration to confirm patency but they were unable to aspirate.The hcp took the patient under x-ray but they could not see the catheter.The hcp requested to have a manufacturing representative (rep) come and confirm the placement of the catheter.The rep stated they would look but could not say with absolute certainty that they could see the catheter and the tip and confirm that it was intact.No symptoms were reported.It was reported this occurred on (b)(6) 2019.No further complications were reported or anticipated.

Manufacturer Narrative

Product id 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2019-06.Product type catheter.Information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative (rep).The rep reported they had not looked at the imaging that was performed.It was reported the patient had a full revision of their catheter and their pump which was 5 months from end of service (eos).The cause of the inability to aspirate the catheter was not determined.Once the pump was exposed at the revision the healthcare provider tried to aspirate and only retrieved 3 ml of fluid so they decided to replace the catheter.The cause of the inability to see the catheter on x-ray was also not determined.The patient's weight was unknown.It was indicated the information provided had been confirmed with the physician/account.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturing representative (rep).The rep reported that the explanted catheter would not be returned for analysis.The reason was not provided.

• 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: 8652273
• MDR Text Key: 146541167
• Report Number: 3004209178-2019-10498
• 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
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2014
• 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: 06/17/2019
• Date Device Manufactured: 10/22/2012
• 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: 18 YR