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

Model Number 8637-20

Device Problems Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2017

Event Type  Injury  

Event Description

Information was received from a manufacturer representative regarding a patient receiving gablofen at an unknown concentration and dosage via intrathecal drug delivery pump for intractable spasticity and head/brain injury.It was reported there was an alarm due to an elective replacement indicator (eri) via non-critical alarm.It was also reported a low reservoir alarm.The logs showed multiple reset occurred - low battery, pump in safe state.The pump was replaced.There were no reported symptoms.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Additional information was reported by the company representative via a healthcare professional (hcp) on (b)(6) 2017.Pump logs showed the pump had been used to deliver baclofen, also reported as lioresal, (2000 mcg/ml at 11.9 mcg/day).On (b)(6) 2017 multiple resets and low battery resets occurred.It was noted that pump was replaced due to ¿rotor stops ¿ safe state, etc¿ and the patient had a gradual loss of therapy, recovered without sequela, and was without injury.On (b)(6) 2017 the company representative later clarified that the pump had been used to deliver gablofen.No further complications were reported.

Manufacturer Narrative

Analysis of the pump found that there was high resistance in the pump battery.Eval code-result updated.Eval code-conclusion updated.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.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

Additional information was provided by the hcp on 2017-mar-27, stating the patient¿s weight.

Manufacturer Narrative

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

Manufacturer Narrative

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6362754
• MDR Text Key: 68464532
• Report Number: 3004209178-2017-04699
• 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: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2011
• 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-2276-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 52