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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Intermittent Infusion (2341); Inappropriate or Unexpected Reset (2959)

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

Event Date 12/04/2016

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 health care provider (hcp) regarding a patient with an implantable drug infusion pump indicated for intractable spasticity and multiple sclerosis.The pump contained an unknown brand of baclofen with a concentration of 500 mcg/ml at a dose of 197.8 mcg/day.It was reported the patient was last seen (b)(6) 2016 and had a normal refill done, and the early replacement indicator (eri) was 19 months.The hcp stated he was doing another refill on (b)(6) 2017 and upon checking the pump status, eri occurred (b)(6) 2016.The hcp stated the concentration and dose had been consistent.The hcp confirmed the eri alarm was occurring; the eri was not expected.No patient symptoms were reported.The hcp stated he played the alarms for the staff at the nursing home and after playing the test alarms, the pump started critically alarming.The hcp stated he was seeing that low battery reset occurred in the logs after he played the test alarms.The hcp stated he needed a report to send to another hcp.The hcp stated he would discuss the replacement further with the other hcp who was over 200 miles away.The hcp requested the emergency procedures be faxed to the nursing home.

Event Description

Additional information was received from an hcp via a manufacturer¿s representative on (b)(6) 2017.It was reported that there was ¿premature battery depletion¿ as well as a motor stall.No environmental/external/patient factors that may have led or contributed to the issue were reported.As troubleshooting performed, the pump logs were interrogated and the pump was replaced.It was detailed that the pump started ¿prematurely alarming¿ and that the logs revealed battery low, eri 16 months, and motor stall occurred with motor stall recovered.Surgical intervention occurred to resolve the issue as the pump was replaced on (b)(6) 2017.At the time of the report the patient was ¿alive ¿no injury¿and the issue was resolved.It was noted that the baclofen in the pump was lioresal [500 mcg/ml] at a dose of 197.68 mcg/day.It was indicated that the pump would be returned and that a printout of the logs would be included with the pump in the return mailer box.

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 the company representative (rep) via the return paperwork and the pump logs were provided.The current pump settings last examined at (b)(6) 2017 (last change (b)(6) 2017) showed the patient was receiving lioresal.Multiple low battery resets occurred starting on (b)(6) 2017 and the pump was in safe state on (b)(6) 2017 at 16:21.The motor stall recovery occurred on (b)(6) 2017 16:21.

Manufacturer Narrative

Correction: due to the reported surgical intervention required, this event is being reported as a serious injury.Analysis of the pump found high battery resistance.Result code and conclusion code no longer apply.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6272867
• MDR Text Key: 65608193
• Report Number: 3004209178-2017-01560
• 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: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2011
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR