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

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2022

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving baclofen (2000 mcg/ml at 1651 mcg/day), fentanyl (3250 mcg/ml at 2683 mcg/day), bupivacaine (20 mg/ml at 16.5 mg/day), and clonidine (325 mcg/ml at 268 mcg/day) via an implanted pump.It was reported that during the routine pump replacement for eos (end of service), the hcp attempted cap (catheter access port) aspiration and was unable to attain csf (cerebrospinal fluid).The hcp explored the posterior location of the catheter insertion and found the catheter to be cut.The existing catheter was removed and replaced with a new one.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The existing medication was diluted by 50% with pfns (preservative free normal saline) and the medication doses were reduced.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: ubd: 14-oct-2017, udi#: (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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14641525
• MDR Text Key: 293612750
• Report Number: 3004209178-2022-07381
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• 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: 06/04/2022
• Date Device Manufactured: 10/16/2015
• 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: 53 YR
• Patient Sex: Female