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

Model Number 8637-40

Device Problems Failure to Disconnect (2541); Battery Problem (2885); Device Operates Differently Than Expected (2913)

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

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 10-jun-2012, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) via a device manufacturer representative regarding a patient receiving lioresal (500 mcg/ml at 100 mcg/day) via an implantable infusion pump.It was reported that during a surgery on (b)(6) 2018 the hcp was attempting to disconnect the catheter from the pump and the silicone covering on the catheter slid off.The hcp had been trying to pinch the catheter in different areas to attempt to remove the catheter from the pump.The catheter was trimmed and a new catheter was added, and the pump was left implanted.It was also noted that there was "something inside the clear silicone near the access port." two attached images showed a catheter and pump inside a biohazard bag (note this conflicts with the report that the pump was left implanted).No patient symptoms were reported.The issue was considered resolved.The patient's status at the time of the report was alive - no injury.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 health care provider (hcp) via a device manufacturer representative on (b)(6) 2018.It was clarified that the hcp noticed "something inside the clear silicone near the access port" on the pump.No further complications were reported.

Manufacturer Narrative

Analysis results were not available at the time of this report.A supplemental report will be submitted when analysis is completed.

Event Description

Additional information was received from a health care provider (hcp) via a device manufacturer representative on 2018-may-02.The patient had been scheduled for a pump replacement on (b)(6)2018 and it was during this surgery that the catheter issue was noted.No further complications were reported.Additional information was received from a health care provider (hcp) via a device manufacturer representative on (b)(6)2018.It was reported that the pump had been removed on (b)(6)2018 as the battery was depleted.No further complications were reported.

Manufacturer Narrative

Analysis of the implantable infusion pump (s/n (b)(4)) found overinfusion - undetermined root cause.Analysis of the implantable intrathecal catheter (s/n (b)(4)) found a non-significant indent in the seal which did not affect infusion.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: 7426308
• MDR Text Key: 105318341
• Report Number: 3004209178-2018-07906
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2012
• 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: 29 YR