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

Model Number 8637-20

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 04/01/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiv ing an unknown drug via an implantable pump for failed back surgery syndrome and spinal pain indications.It was reported that the patient's catheter was migrating more anterior than posterior.It was unknown if there were any external factors that contributed to the event.X-rays were taken but the dates are unknown.The patient is scheduled for a catheter revision on (b)(6) 2022.The event was not resolved at the time of the report.

Manufacturer Narrative

Concomitant medical products: product id 8780.Serial# (b)(4).Implanted: (b)(6) 2021.Product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 23-jun-2023, 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: 14218452
• MDR Text Key: 290150863
• Report Number: 3004209178-2022-05294
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• UDI-Public: 00763000422608
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Date Device Manufactured: 08/24/2021
• 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: 82 YR
• Patient Sex: Female