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

Model Number 8637-20

Device Problem Insufficient Information (3190)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, serial#: (b)(4), implanted: (b)(6) 2009, product type: catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 06-may-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2020 (b)(4) (rep): information was received from a company representative regarding a patient who was receiving baclofen of an unknown concentration at an unknown dose rate via an implantable pump for intractable spasticity.It was reported that the company representative was to assist with a catheter dye study on (b)(6) 2020 because there were questioning if the therapy was working appropriately.The date of the event was unknown.It was indicated that no further history was known at this time.No further patient complications have been reported as a result of this event.(b)(6) 2020 (rep): additional information was received from the company rep.The initial reporter was indicated to be physician (b)(6).It was clarified the patient wasn't getting relief from their therapy.The dye study was performed but no dye was seen.The doctor felt there was an issue with the patient getting medication.The catheter was replaced and the old one was tied off in the patient.It was reported the patient was now getting relief.The patient's weight was unknown.

• 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: 10819309
• MDR Text Key: 217313916
• Report Number: 3004209178-2020-19703
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: Other
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Date Device Manufactured: 01/23/2018
• 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 Outcome(s): Required Intervention