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

Model Number 8637-40

Device Problems Obstruction of Flow (2423); Improper Flow or Infusion (2954); Insufficient Information (3190)

Patient Problems Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709 , lot# j0056653r, implanted: (b)(6) 2001, product type :catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 20-nov-2002, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal sufenta (concentration and dose unknown) via an implanted pump for spinal pain, non-malignant pain, and failed back surgery syndrome.It was reported every time they do a refill, the patient had overdose type symptoms including lightheadedness and has had to go to the emergency department (ed) after multiple refills because of this.It was noted the patient was concerned a "valve" in the pump may be allowing her to get overdosed after refill and was concerned that the pump would fail completely and overdose her.It was further reported the patient had been having volume discrepancies for some time, but did not specify for how long.He believed the catheter was occluded, however al so stated that the patient wanted the pump out so they had been weaning her down prior to removing the pump.

• 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: 13238040
• MDR Text Key: 284998187
• Report Number: 3004209178-2022-00558
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2018
• 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: 01/11/2022
• Date Device Manufactured: 12/20/2016
• 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 Sex: Female