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

Model Number 8637-40

Device Problems Device Alarm System (1012); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483); Pumping Stopped (1503); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Appropriate Term/Code Not Available (3191)

Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8840, product type: programmer, physician.(b)(4).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 foreign healthcare provider (hcp) via a clinical study regarding a patient who was receiving gablofen (2,000 mcg/ml at 549 mcg/day) via an implantable pump for an unknown indication for use.It was reported that when the hcp went to refill the pump on (b)(6) 2017, they saw the message ¿a terminal event occurs.¿ the event noted was end of service (eos).The hcp also found 15 cc of baclofen in the pump.Surgical intervention did not occur, but was planned.It was not scheduled yet.The product would not be replaced in the future.There were no external factors that may have led or contributed to the issue.No troubleshooting was performed.The product status at the time was implanted ¿ out of service.The issue was not resolved.The patient status was alive ¿ no injury.There were no reported symptoms.No further complications were anticipated.The pump logs were reviewed.The pump was examined on (b)(6) 2016; the elective replacement indicator (eri) was at 21 months.The pump was then examined on (b)(6) 2017.It was discovered that the eri was at 16 months, but the eri had already occurred on (b)(6) 2016.Eos occurred on (b)(6) 2017, with a tube set message appearing two days later.It was also noted that the pump was stopped due to end of service, and the replace by date was noted as (b)(6) 2017.

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.It was reported that the doctor think that no critical alarm occurred at all.No further complications were reported and/or anticipated.

Manufacturer Narrative

(b)(4) no longer applies.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.It was reported that the patient did not experience any symptoms related to the pump reaching end of service (eos).It was reported that there was no critical alarm.It was noted that the doctor know the baclofen was not efficient on this patient.It was noted that there was no explant date for the pump for the moment.

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.It was reported that the pump has been explanted.No further complications were reported and/or anticipated.

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.It was reported that the implant date of the pump was (b)(6) 2011.It was further noted that the pump didn¿t work so treatment was not given to the patient.No further complications were reported and/or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the pump, model# 8637-40, serial#(b)(4), found high battery resistance.Analysis of the unknown catheter found user related holes in the catheter body.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: 6404631
• MDR Text Key: 69946398
• Report Number: 3004209178-2017-05594
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/27/2017

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: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 07/25/2017; 07/25/2017
• Supplement Dates FDA Received: 03/14/2017; 03/28/2017; 03/29/2017; 06/07/2017; 06/12/2017; 07/27/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2011
• 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