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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Aspiration Issue (2883); Patient Device Interaction Problem (4001)

Patient Problems Host-Tissue Reaction (1297); No Known Impact Or Consequence To Patient (2692); Fibrosis (3167)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, lot# n501770003, implanted: (b)(6) 2015, product type: catheter, other relevant device(s) are: product id: 8781, serial/lot #: n501770003, (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 daiichi regarding a patient receiving gabalon with an unknown concentration at 50 mcg/day via an implantable pump for hypoxic ischemic encephalopathy.It was reported that the catheter was suspected/seemed to be occluded.A catheter replacement operation was scheduled to be performed on (b)(6) 2018.Details were scheduled to be confirmed during the operation on (b)(6) 2018.Aspiration from the catheter access port (cap) failed when confirming the contrast examination of the catheter, so the contrast examination could not be performed.Retrieving the catheter would be requested during the operation on (b)(6) 2018.The classification of severity was noted as ¿6 (serious)¿.The causality was not related to the drug or programmer.It was unknown if the causality was related to the catheter, pump, or surgical procedure.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 daiichi.It was reported that the contrast exam inanition of the catheter was suspended after catheter access port (cap) aspiration failed.Although the catheter was suspected to be occluded, a ¿kink etc.¿ was not observed.Fibrous substance like granulation was seen in the ¿cap of the pump side catheter¿.As there was no ¿kink etc.¿, it was assumed that the substance like sheath was formed at the catheter tip or something occluded in the catheter.Fibrous substance like granulation was seen in the ¿cap, which was attached to the pump¿.It was suspected that something entered through the ¿gap of the cap, and fibrous substance was formed¿.It was initially reported that the catheter was in the medullary cavity.However, it was later clarified that the catheter was in the proper location/intrathecal space.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis found a user-related hole in the catheter body.(b)(4).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): 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: 7607151
• MDR Text Key: 111257931
• Report Number: 3004209178-2018-13580
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2014
• 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: 10 YR