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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Mechanical Jam (2983)

Patient Problem Muscle Spasm(s) (1966)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a consumer receiving lioresal [2000 mcg/ml] at a rate of 197.1 mcg/day via intrathecal drug delivery pump for intractable spasticity.It was reported that there was a motor stall seen at initial interrogation.The patient recently had an mri and did not have the pump interrogated on the day of the mri.The motor stall occurred on the same day of the mri and when the patient was seen on (b)(6) 2017, her next scheduled refill date, and the pump was still stalled.The patient reports that the pump is still alarming and she doesn't feel any better, including sudden increased spasms.

Manufacturer Narrative

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

Event Description

Additional information received reported that the patient came in to see the healthcare provider on (b)(6) 2017.Per the patient they had an mri in (b)(6).When the patient saw the healthcare provider in july the patient¿s pump was in a motor stall, exceeding pump tubing time.The environmental, external or patient factors that may have led or contributed to the issue was the motor stall did not recover after an mri.The diagnostics and trouble shooting were reported as a rotor study was performed and the healthcare provider was able to restart the pump with the 8840 physician programmer.The actions and interventions taken to resolve the issue were the patient was referred for a pump replacement.The pump was explanted on (b)(6) 2017.The issue was resolved at the time of the report and the patient¿s status was noted as alive, no injury.No further patient complications were reported or anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

The pump and catheter were returned to the manufacturer.

Manufacturer Narrative

The pump was returned, and analysis found no evidence of anomalies.(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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6787231
• MDR Text Key: 82784817
• Report Number: 3004209178-2017-17264
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2016
• 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 Age: 61 YR