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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Intermittent Infusion (2341); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2017

Event Type  Injury  

Event Description

Information was received from a health care professional (hcp) and a patient the patient was receiving gablofen (concentration 2000 mcg/ml, dose 1999.9 mcg/day) via an implantable pump for intractable spasticity and multiple sclerosis.A motor stall was seen at initial interrogation and it was unknown as to whether patient recently had a magnetic resonance imaging (mri).The patient was admitted to the hospital 6 days prior to this report date and was discharged on this report date.The pump status/event logs indicated that there were multiple stalls and recoveries with the first stall occurring 5 days prior to this report date at 2:15 and the the last stall occurring the day prior to this report date at 7:32 and was still active.Each of the stalls lasted 10-12hrs.The hcp was with the patient and asked the patient if he knew of any mris or exposure to other electromagnetic interferences (emi) or magnets, the patient did not know for certain what type of equipment he was exposed to.It was noted that the patient had a wound vac hooked to his coccyx but that had been on since (b)(6) so they could rule that out.There were no symptoms reported.No further complications were reported.

Manufacturer Narrative

Analysis found that there was corrosion/wear/lubrication in the pump motor gear train.Analysis also found that there was a stall due to shaft bearing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device code (b)(4) has been updated to (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a company representative.The patient recently had magnetic resonance imaging (mri).The representative was called to the hospital where the patient was in the intensive care unit (icu).The logs show a message of stop pump period may exceed tube set.A pump replacement was planned for (b)(6) 2017.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional via manufacturer representative.It was reported that the cause of the multiple stalls had not been determined, and was unknown why the patient was admitted to the hospital.The pump had been sent back to the manufacturer at the time of this report.No further complications were reported.

Manufacturer Narrative

Interrogation of the returned device revealed the pump had been programmed to deliver 12.8 mcg/day of gablofen in minimum rate mode (at the previously reported 2,000 mcg/ml concentration).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 was returned to the manufacturer for analysis.

• 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: 7047959
• MDR Text Key: 92589375
• Report Number: 3004209178-2017-24117
• 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,consum
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2012
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR