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

Model Number 8637-40

Device Problems Difficult to Advance (2920); Positioning Problem (3009)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 8781, serial# (b)(4), product type catheter, product id 8780, serial# (b)(4), implanted: (b)(6) 2021, product type catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 09-jul-2021, udi#: (b)(4); product id: 8781, serial/lot #: hg3h0y008, ubd: 12-jun-2021, udi#: (b)(4).The catheters were returned and analysis identified an anomaly to the catheter/guide wire.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving gablofen (500 mcg/ml at 75 mg/day) via an implanted pump.It was reported that during the initial implant procedure the doctor was advancing the catheter when the wiring was coming out and the catheter bent.He was unable to get placement, so asked for another catheter to be opened.The same issue occurred, and he asked for another catheter to be opened.He was then able to get placement and the wiring didn¿t come out.The environmental, external, or patient factor that may have led or contributed to the issue was noted to be ¿patient¿s spinal anatomy¿.The issue was resolved, and it was indicated that the hcp had no further information to provide regarding the event.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11581793
• MDR Text Key: 246077119
• Report Number: 3004209178-2021-05055
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• 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: 03/23/2021
• Date Device Manufactured: 12/09/2020
• 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 Age: 9 YR
• Patient Weight: 36