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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Aspiration Issue (2883)

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

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2004, explanted: (b)(6) 2018, product type: catheter, product id: neu_unknown_cath, serial# unknown, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), (b)(6), (b)(4); product id: neu_unknown_cath, serial/lot #: unknown, (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a device manufacturer representative regarding a patient who was receiving morphine (unknown concentration and dosage) via an implantable infusion pump for degenerative disc disease/herniated disc pain and spinal pain.It was reported that a catheter event was confirmed.The patient was seen for a normal pump replacement.The healthcare provider (hcp) was unable to aspirate the catheter, so the hcp replaced the catheter with a new catheter.The new catheter kept becoming obstructed and retrograding, so the hcp took out the new catheter.The hcp left the new pump inside the patient and was planning on putting the pump into minimum rate.A catheter was going to be added at a later date.No patient symptoms were reported.No further complications were reported.

• 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: 7553403
• MDR Text Key: 109535220
• Report Number: 3004209178-2018-12126
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 05/30/2018
• Date Device Manufactured: 09/08/2011
• 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: 68 YR