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

Model Number 8637-20

Device Problems Failure to Interrogate (1332); Material Integrity Problem (2978)

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

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id 8709sc, lot# n237666008, implanted: (b)(6) 2010, explanted: (b)(6) 2016, product type: catheter.

Event Description

Information was received from a health care professional via a manufacturing representative (rep) regarding a patient whose pump contained saline at the time of the event, it was noted that the pump contained saline for the past 2months prior to this event report date.The patient's indication for use was non-malignant pain and other chronic/intract pain.The pump was implanted in 2010 so the patient was due for a replacement pump.The pump had reached end of life and could not be read prior to explant.On this report date, the patient was scheduled for a pump replacement with possible catheter replacement.The doctor intended to replace the catheter as well and upon removing the old catheter, it was found that the old catheter was broken at the spinal segment where it exited the spine.The doctor did not know that the catheter was broken until the surgery started.There were no diagnostics tests performed, the catheter was simply replaced as previously scheduled and the issue was considered resolved.The cause of the broken catheter had not been determined.To the reps knowledge, the patient did not have any symptoms.The patients status was "alive - no injury".The pump and catheter that were explanted from the patient were to be returned to the manufacturer.

Manufacturer Narrative

The main component of the system and other applicable components are: product id : 8709sc, lot#: n237666008, implanted: (b)(6) 2010, explanted: (b)(6) 2016, product type: catheter.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 the manufacturer's representative.It was reported that the cause of not being able to rea d the pump prior to replacement was because the elective replacement indicator (eri) had occurred.It was stated that after the representative's 8840 programmer indicated that the pump had reached end of life, no further attempts at troubleshooting were made as the pump was already scheduled for replacement.

Manufacturer Narrative

The catheter ((b)(4)) was analyzed and it was found that the catheter body was broken and there was a hole caused by deep abrasion was also found in the catheter body.The pump ((b)(4)) was returned and no significant anomaly was found.(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.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6061947
• MDR Text Key: 58606268
• Report Number: 3004209178-2016-22711
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2011
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 12/01/2016; 12/01/2016
• Supplement Dates FDA Received: 11/17/2016; 12/09/2016; 09/26/2017; 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR