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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Spasm(s) (1966); Seizures (2063)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving baclofen 500mcg/ml at 120 mcg/day via an implantable pump.On (b)(6) 2020 it was reported that the patient was having uncontrolled seizures.The patient went to er (emergency room) per the call the reporter received (b)(6) 2020 from the skilled nursing facility the patient lived in.Per the reporter, the physician did not have privileges at the hospital and was requesting to speak to someone about the pump.Additional information received from the consumer and the company representative reported that the patient was admitted to the hospital because she was having seizures and very spastic.The pump was interrogated and there were no alarms or any issues with the pump, the pump was functioning properly.The environmental, external or patient factors that may have led or contributed to the issue was noted as ¿n/a¿.The diagnostics and troubleshooting performed was they read the pump logs and viewed there were no alarms to report.The actions and interventions taken to resolve the issue was noted as nothing was wrong when interrogating the pump.The issue was resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.The patient status was noted as alive, no injury and no further complications were reported 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: 10362319
• MDR Text Key: 201581497
• Report Number: 3004209178-2020-13401
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Date Device Manufactured: 02/09/2018
• 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): Hospitalization; Other
• Patient Age: 47 YR