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

Model Number 8637-40

Device Problems Kinked (1339); Obstruction of Flow (2423); Aspiration Issue (2883); Infusion or Flow Problem (2964)

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

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, lot# 0214850800, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: 0214850800, (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a clinical study regarding a patient who was being implanted with an infusion pump for an unknown indication for use.It was reported on (b)(6) 2018 that the patient was implanted with an intrathecal catheter for a trial on (b)(6) 2018.On (b)(6) 2018, an implantable infusion pump was placed because of the positive trial.During this operation they did a ¿usual checkup¿ of the system by doing a side-port aspiration but they could not aspirate anything.Flushing was also not possible.The device diagnosis was a catheter kink.They could not find the reason for the obstruction and had to replace the catheter.The event also resulted in in-patient hospitalization.It was indicated the catheter would be returned.The etiology of the event was noted to be related to the device or therapy and not related to the implant procedure.The outcome was resolved without sequelae on (b)(6) 2018.No further complications were reported or anticipated.

Manufacturer Narrative

H6 device codes no longer apply to the event.Conclusion code was updated to 67.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a clinical study.It was reported the pump was delivering intrathecal baclofen 500,0 mcg/ml at 75,05 mcg/day.

Manufacturer Narrative

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

Event Description

Additional information was received froma foreign healthcare professional (hcp) via a clinical study.It was reported the catheter w as not explanted/replaced, it was only revised.The catheter was still implanted and could not be returned to the device manufacturer.

Manufacturer Narrative

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

Event Description

Additional information was received.The intervention of catheter explant/replacement was updated to catheter revision.This was reported to still have occurred on (b)(6) 2018.The etiology was updated to indicated the event was related to the lumbar/pump portion of the catheter, instead of the entire catheter.

Manufacturer Narrative

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

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a clinical study.It was reported the catheter was revised, and the etiology pertained to the lumbar/pump portion.

• 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: 7658950
• MDR Text Key: 113034734
• Report Number: 3004209178-2018-14906
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2019
• 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: 04/15/2019
• Date Device Manufactured: 03/23/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 51