MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Intermittent Infusion (2341); Battery Problem (2885)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966); Pain (1994); No Known Impact Or Consequence To Patient (2692)

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 professional (hcp) via a manufacturer's representative (rep) regarding a patient receiving bupivacaine of an unknown concentration at an unknown dose via an implantable infusion pump for non-malignant pain and failed back surgery syndrome.It was reported that the patient's pump had a motor stall that did recover.It was unknown what circumstances led to the motor stall and subsequent recovery.The patient had not had an mri.It was unknown to rep what troubleshooting was performed related to the motor stall.The issue was not resolved at the time of this report.Surgical intervention was planned for (b)(6) 2017.The patient's status was "alive- no injury" at this time and reported no symptoms.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer's representative (rep) on 2017-mar-08.It was reported that at the time of surgery, the pump was changed, and the current catheter remained.The surgeon decided to decrease the daily dose of both drugs in the pump at the time of surgery, and then turn the pump down to minimum rate later that day.The surgeon was thinking of putting saline into the pump until he can get a lower concentration of drugs to put into the pump.The surgeon said the patient was slightly bradycardic and hypotensive.

Event Description

Additional information was received from a healthcare professional on 2017-apr-07.It was reported that the pump had not supplied any meds as of (b)(6) 2017, a motor stall was confirmed.At the last fill on (b)(6) 2017 there was 9 ml more drug in the pump that expected.When the pump was replaced on (b)(6) 2017 all 40 ml were in the pump.The patient experienced poor pain to no pain control.After the new pump was implanted the dose had to be reduced considerably.The cause of the pump issues was not determined but had been resolved with replacement.The explanted pump was in the pathology department at the hospital.

Event Description

Additional information was received from a consumer (con) on 2017-mar-27.It was reported that the patient's pump was not used anywhere near what it was supposed to due to motor stalls.The patient reported that he believed the pump had failed because when they did a refill they found 40 ml of medication left in the pump and the patient did not know how long the pump had not been giving medication and the patient had been in extreme pain since.The patient reported that he had been to the healthcare professional (hcp) and was told that the pump could not be swapped until (b)(6) 2017.The patient stated he had to go to a hospital to get the pain and spasms under control with hypodermic needles the old fashioned way.The patient's pump was replaced on (b)(6) 2017.The patient stated he was also taking 10 mg diazepam or valium to help the patient sleep at night.The patient was diagnosed with issues in his right hip, and stated that his right hip was replaced on (b)(6) 2015.The hcp did standard x-ray to find out what the issues going on with the right hip was that was causing the patient additional pain.The patient stated that the hcp did not know if it was positional but patient's left shoulder and left hip hurt like "bloody blue blazes".The patient stated that in 2011 he had stimulation done by a different doctor that failed and when that doctor ran out of natural bone growth during the procedure; decided to use some synthetic material and it lasted all of 16-18 months and failed.The patient stated he walked around on crutches or in a wheelchair and 6-8 vertebrae are destroyed due to issues because of this surgery.

Event Description

Additional information was received from a consumer (con) on 2017-may-26.It was reported that the patient was told that he pump was supposed to last the full duration of 7 years.Per the patient, there was a tremendous foul up with his pump that was implanted in 2010 and was told it would last and work, collectively and with some kind of quality, all the way up to 2017.The patient did not know why it cut out, why it stopped or whatever.The patient was under surgery and had been sick with gastro intestinal problems from other unrelated sources with all the surgeries prior from 2015.The patient had been sick since the tail end of 2016 and it had not cleared out but that the patient did not know what it was.Patient stated he had no idea what the cause of it was or anything else; stating he had to go in for emergency surgery in (b)(6) 2016.

Event Description

Additional information was received from a consumer (con) on 2017-jun-17.It was reported that it was determined the batteries in the pump failed and they did not know how long they had been failed.

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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6345220
• MDR Text Key: 67823623
• Report Number: 3007566237-2017-00735
• 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: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2011
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2017
• Date Device Manufactured: 01/27/2010
• 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 Outcome(s): Required Intervention