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

Model Number 8637-40

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8781, product type: catheter.Other relevant device(s) are: if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving compounded baclofen, dilaudid (hydromorphone), and bupivacaine via an implantable pump for unknown indications for use.It was reported that the patient had worsening lower back pain radiating to lower extremity on (b)(6) 2021.The baclofen rate was decreased at the last visit.The it rate was increased at current visit.It was indicated the event was related to the device or therapy and related to the decreased dose of baclofen.The event was ongoing.Additional information was received from the healthcare provider via a clinical study indicated that a catheter access port study revealed the catheter tip had migrated from t6 to c7-t1.The patient's worsening pain was resolved with an it rate increase.There is no plan to revise the catheter.

• 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: 14186358
• MDR Text Key: 289884706
• Report Number: 3004209178-2022-05106
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2019
• 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: 04/22/2022
• Date Device Manufactured: 03/16/2018
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 67 KG