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

Model Number 8637-20

Device Problems Device Alarm System (1012); Electromagnetic Interference (1194); Pumping Stopped (1503); Inappropriate or Unexpected Reset (2959); Mechanical Jam (2983)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2017

Event Type  Injury  

Event Description

Information was received from a healthcare provider regarding a patient receiving baclofen 500mcg/ml at 108mcg/day via an implantable pump.The indications for use were intractable spasticity and multiple sclerosis.The healthcare provider reported that the patient had an mri the morning of the report.The patient called the healthcare provider about an hour after the mri and reported that the pump was beeping.The healthcare provider requested to know why the pump would be beeping.No troubleshooting was performed.The patient was a few hours away so the healthcare provider had not yet seen the patient.The healthcare provider was wondering if he should have the patient come in today to read the pump.The mri effects and mri labeling were reviewed with the healthcare provider.It was also reviewed that the pump should stop alarming if it was due to the potential motor stall caused by the mri.It was also reviewed that there could be another cause for the alarm and best practice would be to interrogate the pump and check the logs.The healthcare provider would call the patient back to see if the pump was still alarming and then would make a decision if the patient should come in today or wait until monday or tuesday of next week.Additional information received reported that the pump logs were checked and a critical alarm was occurring, low battery reset occurred.The healthcare provider extended the alarm interval and programmed the pump to minimum rate mode.The patient would be scheduled for a pump replacement.There were no patient symptoms and 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.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Additional information was received from the company representative (rep) indicated the pump was replaced on (b)(6) 2017 and a critical alarm occurred due to low battery reset.The pump was replaced and it was still alarming ¿every five seconds¿ despite the reporter¿s efforts to silence the alarm.The pump logs were also provided via the return paperwork.The pump logs provided last examined (b)(6) 2017 (last change (b)(6) 2017) showed a motor stall occurred and a reset occurred.The pump was in safe state.The estimated elective replacement indicator (eri) was 12 months.The patient¿s replacement pump was used to deliver intrathecal gablofen 500 mcg/ml in flex mode at 107.93 mcg/day.

Manufacturer Narrative

Analysis of the pump found high battery resistance.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 a user facility on 2017-may-09.It was stated that approximately 6 years ago, the patient with a diagnosis of increasing spasticity had an implantable programmable infusion pump for drug delivery of baclofen.It was reported that on (b)(6) 2017, the patient underwent magnetic resonance imaging (mri) studies and the pump began to alarm approximately one hour after the customer had arrived back home.It was stated that the warning beep continued through the day.The patient contacted his healthcare provider and withdrawal symptoms were covered by oral baclofen.It was reported that the patient experienced more spasticity because of the change in baclofen administration.The patient and physician arranged to meet at the facility.It was reported that the physician noted that interrogation of the pump revealed that there was a motor stall a the time of the mri, which was noted as understandable given the effect of the magnet.It was reported that the logs also showed that there was battery failure.The patient's dose was reduced from 109 mcg/day to 3 mcg/day per settings of the pump.It was noted that there were several interrogations to be certain that this was the case.The physician contacted the manufacturer's technical support and reviewed the findings on the programmer.It was stated that while the pump was coming near the end of its useful life, based on analysis of the baclofen pump logs, it appeared that the battery life should have lasted at least until the end of the current calendar year.It was reported that the event caused the patient to develop increased spasticity(as expected with pump failure).It was stated that oral dosing was not effective (oral dose peaks and valleys vs.Continuous iv dosing).It was stated that because of the failure, the patient required surgical replacement of the malfunctioning baclofen pump much sooner than anticipated.No further complication were reported or anticipated.

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: 6474917
• MDR Text Key: 72177086
• Report Number: 3004209178-2017-07876
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/12/2017

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: 11/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 05/04/2017; 05/04/2017
• Supplement Dates FDA Received: 04/10/2017; 04/17/2017; 05/12/2017; 10/03/2017; 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2011
• 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 Z-2276-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR