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

Model Number 8637-20

Device Problems Premature End-of-Life Indicator (1480); Device Operates Differently Than Expected (2913); Inappropriate or Unexpected Reset (2959); Material Integrity Problem (2978)

Patient Problems Fatigue (1849); Nausea (1970); Pain (1994); Chills (2191); Therapeutic Response, Decreased (2271)

Event Date 09/04/2017

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 consumer via a company representative regarding a patient receiving morphine 50 mg/ml, bupivacaine 25 mg/ml and fentanyl 10.000 mcg/ml, doses not reported via an implantable pump.The indications for use were non-malignant pain and other chronic/intract pain (trunk/limbs).It was reported that the patient contacted the company representative and complained about an alarm beeping every 10 minutes.The patient complained of nausea, shivering, tiredness and increased pain.There were no patient factors that led to this event.The diagnostics and troubleshooting performed were the pump was interrogated and the reading showed eri (elective replacement indicator) 3 months and also the pump showed eos (end of service).The pump stopped working due to eos (end of service).The patient is on the schedule for replacement on (b)(6) 2017.The issue was resolved at the time of the report.The patient status was noted to be alive, no injury and there were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received reported that the printout was showing eri 3 months and the pump in safe state, reset occurred.It was also noted the pump infusion was turned to minimum rate.The dose drug doses per day were noted as morphine 0.302mg/day, bupivacaine 0.151mg/day and fentanyl 60mcg/day.The cause of the pump stopped working was reported as end of life.The pump was to be replaced today (b)(6) 2017.No further patient complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected information: device code (b)(4) no longer applicable.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id 8709 (b)(4) implanted: (b)(6)2003 explanted: (b)(6)2017 product type catheter if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a consumer (patient¿s wife) reported the patient¿s second pump depleted 3 months early.The consumer stated they were not sure why, but it just stopped.The consumer stated she thought it was the staff in the doctor¿s office as the reason the pump quit.The consumer stated when they went to put in the new pump, they found the catheter was corroded.The consumer stated the event occurred (b)(6)2017.

Manufacturer Narrative

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

Event Description

Additional information was received reported that the cause of the pump showing eri (elective replacement indicator) 3 months and the pump also showing eos(end of service) was pump was at end of life, approx.7 years.The healthcare provider sent the patient for pain management to the er (emergency room).In regards to clarification of the catheter corrosion it was noted, no catheter corrosion.At the pump exchange the physician could not aspirated the catheter and exchanged it for a new one.There were known symptoms related to the catheter ¿corrosion¿, the pump was at eos and went into withdrawal.The replacement of the devices resolved the issue.The explanted catheter went to pathology and would not be returned.

• 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: 6844801
• MDR Text Key: 84966726
• Report Number: 3004209178-2017-18792
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• Date Device Manufactured: 07/19/2010
• 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 Z-2276-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR