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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

Patient Problems Headache (1880); Nausea (1970); Pain (1994); Dizziness (2194); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 03/22/2017

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 on (b)(6) 2017 regarding a patient's implanted infusion pump containing bupivacaine (0.1mg/ml at 0.4495mg/day) and morphine (20mg/ml at 8.99mg/day).The indications for use included non-malignant pain and lumbar radiculopathy.It was reported that the patient's pump was alarming, and via telemetry, it was found that the elective replacement indicator (eri) occurred on (b)(6) 2017, followed by multiple resets and low battery resets on (b)(6) 2017, and finally end of service (eos) on (b)(6) 2017.The patient was not doing very well and was getting worse, with flu-like symptoms, wooziness, headache, nausea, and increased pain.The symptoms started gradually on the morning of (b)(6) 2017, and slowly got worse.Surgery was scheduled for (b)(6) 2017 at 15:00 to replace the pump.

Event Description

Additional information received reported that during the pump replacement procedure it was noted that they elected to change the catheter connector.No further complications were reported/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

No further complications were reported or expected.

Manufacturer Narrative

Concomitant products: product id: 8731, serial# (b)(4), implanted: (b)(6) 2004, product type: catheter.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 that the pump had premature eos (end of service).The company representative was in the revision case and stated that the catheter was not patent so they were revising the catheter.They ended up replacing the connector and 23 cm of catheter.It was additionally noted that on (b)(6) 2017 the patient heard the alarm.On (b)(6) 2017 the home care agency interrogated the patient¿s pump and premature eri (elective replacement indicator) alarm had been occurring.The reporter stated it was premature because on (b)(6) 2017 it showed 12 months until eri (elective replacement indicator).On (b)(6) 2017 eos (end of service) alarm, critical alarm occurred.The patient started experiencing early stages of withdrawal.On (b)(6) 2017 the pump was successfully replaced.No further complications were reported/anticipated.

Event Description

Additional information was received and it was reported that the cause for the low battery resets, eri (elective replacement indicator), and eos (end of service) was unknown.The pump was explanted and the patient¿s symptoms resolved.No further complications were reported/anticipated.

Manufacturer Narrative

The pump had been programmed to deliver 1.0 mg/ml of bupivacaine at 0.4455 mg/day, rather than 0.1 mg/ml of bupivacaine at 0.4455 mg/day, as initially reported.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4).

Event Description

The device was returned to the manufacturer on april 05, 2017.

Manufacturer Narrative

Analysis of the pump found low battery reset of an undetermined root cause.Conclusion code ¿ is being updated for this event.Result code no longer applies.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.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.

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: 6432814
• MDR Text Key: 70857208
• Report Number: 3004209178-2017-06345
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2011
• 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: 52 YR
• Patient Weight: 80