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

Model Number 8637-20

Device Problems Premature Elective Replacement Indicator (1483); Inappropriate or Unexpected Reset (2959)

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

Event Date 02/20/2017

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 patient receiving gablofen 300 mcg/ml at 127.04 mcg/day via an implantable pump.The indications for use were intractable spasticity and multiple sclerosis.The healthcare provide reported an non-critical alarm was occurring.The healthcare provider stated eri (elective replacement indicator) was occurring.It was noted that at the last refill on (b)(6) 2017 the eri (elective replacement indicator) was 16 months.Per the healthcare provider the alarm was unexpected.The healthcare provider stated that the patient¿s managing healthcare provider was out of the country so the healthcare provider would be calling a surgeon to discuss scheduling a pump replacement as soon as possible.The healthcare provider also reported that they had aspirated the catheter to ensure it was patent prior to scheduling the replacement.When programming the priming bolus the pump started to critically alarm and stated the pump was in safestate, reset occurred.It was recommended to replace the pump as soon as medically possible.The healthcare provider stated that the patient was scheduled for a consult with the surgeon next friday but they would try to move that up.There were no reported patient symptoms.

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

Additional information was received on 06-mar-2017 and it was reported that the pump was replaced.

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

Additional information received reported the troubleshooting included interrogating the pump and calling the manufacturer and the company representative.The actions and interventions were reported as eri alarm (b)(6) 2017, safe state and reset (b)(6) 2017.Per the healthcare provider the cause of the messages were battery performance issue, pump was implanted (b)(6) 2011.The issue was resolved.The itb (intrathecal baclofen ) pump was replaced (b)(6) 2017.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 received from a manufacturer representative regarding a patient who was receiving lioresal with a concentration of 500.0 mcg/ml at a daily dose of 3.04 mcg/day by minimum rate infusion via an implantable pump.Pump activity logs indicated that low battery resets occurred on (b)(6) 2017 at 12:41, 12:42, and 12:44.

Manufacturer Narrative

Analysis of the pump on 2017-apr-12 revealed high battery resistance.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6356004
• MDR Text Key: 68218561
• Report Number: 3004209178-2017-04516
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/05/2017

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: 07/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 04/12/2017; 04/12/2017
• Supplement Dates FDA Received: 03/07/2017; 03/09/2017; 03/23/2017; 05/05/2017; 10/02/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2011
• 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 Z-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR