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

Model Number 8637-20

Device Problems Intermittent Infusion (2341); Application Program Problem (2880); Inappropriate or Unexpected Reset (2959); Data Problem (3196)

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

Event Date 02/15/2017

Event Type  Injury  

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was receiving baclofen 2000 mcg/ml; 800-to 950 mcg/day via an implantable pump.Indication for use was intractable spasticity and cerebral palsy.The date of the event was approximately (b)(6) 2017.It was reported the patient experienced a return of patient symptoms "about 3 weeks ago¿.On (b)(6) 2017 the hcp was troubleshooting the patient¿s return of symptoms/increased tightness.A catheter access port (cap) aspiration was done and good flow was confirmed.Upon programming the priming bolus to fill the catheter back up with drug the pump suddenly started alarming.Attention dialogue box was noted.Reset occurred-low battery, motor stall recovery occurred.The hcp reported the only logs in the event log were from today.No motor stall occurred message could be found.A critical alarm occurred.Motor stall occurred.Low battery reset occurred.Reset occurred safe state occurred.The pump logs were checked.The pump was successfully updated to the new dose of 950mcg/day but the priming bolus could not be programmed because every attempt caused pump alarms.No further complications were reported/anticipated.

Event Description

Additional information was received from a healthcare provider and via a business partner.It was reported that the patient experienced a return of symptoms on an unspecified date in (b)(6) 2017.On (b)(6) 2017, because the physician could not reprogram a bolus and dosing for the pump, a revision of the pump was performed and the patient did well.It was noted that there were no catheter issues.Following the pump low battery reset and safe state was the increased tone.The pump was replaced due to an end of life (eol) and discarded.As of (b)(6) 2017, the issues had been resolved.

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.

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: 6439803
• MDR Text Key: 71057759
• Report Number: 3004209178-2017-06508
• 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: health professional,other
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Date Device Manufactured: 04/04/2011
• 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-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Weight: 48