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

Model Number 8637-40

Device Problems Intermittent Infusion (2341); Battery Problem (2885)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Date 02/23/2018

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 healthcare provider via a company representative regarding a patient receiving gablofen 2000mcg/ml at 1706.1mcg/day via an implantable pump.The indications for use were intractable spasticity and post spinal cord injury.Premature battery depletion (<(><<)>7 years) was reported.Per the reporter, the patient reported return of spasticity.The diagnostics and troubleshooting performed was they interrogated the pump with logs and showed motor stalls unrelated to refill or mri.There were no known environmental, external or patient factors that led or contributed to the issue.The pump was successfully replaced and the issue was resolved at the time of the report.The patient status was noted as alive, no injury.No further complications were reported.

Manufacturer Narrative

Device code (b)(4) is no longer applicable for this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received and it was clarified that premature battery depletion did not occur.Neither eri (elective replacement indicator) or eos (end of service) occurred.The pump had motor stalls.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the pump found ¿pump motor gear train anomaly ¿ corrosion and/or wear and/or lubrication¿ and ¿pump motor gear train anomaly ¿ stall due to shaft/bearing¿.Conclusion code (b)(4) is no longer applicable for this event.If information is provided in the future, a supplemental report will be issued.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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7298691
• MDR Text Key: 100999501
• Report Number: 3004209178-2018-04020
• Device Sequence Number: 1
• Product Code: LKK
• 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: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 02/28/2018; 03/05/2018; 04/05/2018
• Supplement Dates FDA Received: 03/01/2018; 03/06/2018; 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR