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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Difficult to Interrogate (1331); Pumping Stopped (1503)

Patient Problems Fatigue (1849); Pain (1994); Therapeutic Response, Decreased (2271); Obstruction/Occlusion (2422); Ambulation Difficulties (2544)

Event Date 05/09/2016

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

On 2016-05-12, information was received from a consumer via a company representative regarding a (b)(6), male patient who was receiving fentanyl 100mcg/ml at 83.99 mcg/day, clonidine 400mcg/ml at 335.97 mcg/day and morphine 25mg/ml at 20.998 mg/day via an implantable pump for failed back surgery syndrome and non-malignant pain.On (b)(6) 2016, the patient's arm hurt, but his arm always hurt.On (b)(6) 2016, the patient was getting tired and his legs and back were hurting.By (b)(6) 2016, the patient couldn't keep his eyes open and couldn't walk to get out of his bedroom.The patient was taken to the emergency room (er) that night.A cat scan was done and showed a small bowel obstruction.The obstruction resolved itself.On (b)(6) 2016, the company representative interrogated the pump and the logs showed that a motor stall occurred on (b)(6) 2016 followed by a stopped pump period may exceed tube set.The patient experienced withdrawal as a result and was in the intensive care unit (icu).It was noted the patient did not hear alarms.The patient had not recently had a magnetic resonance imaging (mri); there was no magnetic/electromagnetic interference (emi) exposure that the company representative was aware of.It was later reported by the consumer that the company representative could not interrogate the pump.The consumer saw a personal therapy manager (ptm) code on (b)(6) 2016 but did not remember the code.On (b)(6) 2016, the patient was discharged on a fentanyl patch, clonidine patch and oral morphine until they could get the pump issue resolved.The patient had an appointment with the surgeon on (b)(6) 2016.The cause of the motor stall was unknown.

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

Additional information was received from the company representative (rep) indicated the rep was able to interrogate the pump.It was further reported the small bowel obstruction was not related to the pump and the error code on the ptm that was initially reported was unknown.

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 received reported that the patient had a pump change on (b)(6) 2016 due to a possible motor stall and the patient recovered without sequela.

Manufacturer Narrative

Conclusion code fdc was updated.

Manufacturer Narrative

Analysis of the pump, model# 8637-40, serial# (b)(4), found a gear train anomaly (corrosion and/or wear and-or lubrication).The gear train anomaly/stall was due to the shaft bearing.

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): 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5704070
• MDR Text Key: 46726144
• Report Number: 3007566237-2016-02212
• 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: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2011
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2009
• 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-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR