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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Pumping Stopped (1503); Intermittent Infusion (2341); Device Displays Incorrect Message (2591); Application Program Problem (2880)

Patient Problems Pain (1994); Hot Flashes/Flushes (2153); Chills (2191); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sweating (2444); Sleep Dysfunction (2517)

Event Date 04/22/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8835, serial# (b)(4), product type: programmer, patient.

Event Description

Information was received from a consumer and a healthcare professional (hcp) via a company representative regarding a patient who was receiving morphine 5 mg/ml; 2.5 mg/day and clonidine 1 mg/ml; 1.09 mg/day via an implantable pump.Indication for use was non-malignant pain and post lumbar laminectomy syndrome.Medical history was diabetic neuropathy and parkinson¿s.The date of the event was (b)(6) 2017.It was reported the pump was alarming and had a motor stall.Factors that may have led or contributed to the issue were the patient falls frequently.The patient had magnetic resonance imaging (mri) a few weeks prior and the motor recovered.The motor stall occurred (b)(6) 2017 at 17:49 and motor stall recovery occurred (b)(6) 2017 at 15:00.Since then the patient did not have issues until (b)(6) 2017 when they got a motor stall code on the personal therapy manager (ptm).The patient attempted to give themselves a bolus without success on saturday (b)(6).The patient saw the code 8476 and informed the physician that the personal therapy manager (ptm) would not give them the bolus.Per the logs, 88 and 89 (attempted bolus and bolus denied) occurred (b)(6) 2017 at 12:34, and (b)(6) 2017 at 11:37, 15:39 and 22:11.The physician had the patient follow up in the office the morning of (b)(6) 2017.The pump was interrogated and indicated three motor stall warnings; (b)(6) (mri) recovered, then (b)(6) at 0242 and (b)(6) 0658 that have not recovered.It was determined the pump motor was still stalled and the pump was currently alarming.The patient experienced pain on a scale of 9/10, sweats and was unable to sleep.The issue was not resolved.Patient was alive - with injury noted as withdrawal, loss of appetite, pain, hot/cold flashes, and chills.Surgical intervention was planned for (b)(6) 2017 for a pump replacement.The pump will be returned to the manufacturer for analysis.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Device code (b)(4) was updated/corrected to (b)(4).Eval code - conclusion code ¿ is being updated for this event.

Manufacturer Narrative

The pump was returned for analysis.The pump logs indicated that the pump had been used to deliver morphine (5 mg/ml at 2.5033 mg/day) and clonidine (1 mg/ml; 0.5007 mg/day).Pump analysis found gear train anomalies of a stall due to shaft bearing and corrosion, wear, or lubrication.(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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6522464
• MDR Text Key: 73728336
• Report Number: 3004209178-2017-09089
• 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: Other
• Remedial Action: Recall
• 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: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2012
• 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; Z-0592-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR