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

Model Number 8637-40

Device Problems Intermittent Infusion (2341); Device Operates Differently Than Expected (2913)

Patient Problems Dyspnea (1816); Pain (1994); Numbness (2415)

Event Date 06/29/2017

Event Type  Injury  

Event Description

Information was received from a health care provider (hcp) regarding a patient with an implantable drug infusion pump indicated for non-malignant pain and chronic low back pain.The pump contained an unknown brand of morphine with an unknown concentration at a dose of 2.5 mg/day.It was reported the patient was in the emergency room (er) with symptoms of numbness, increase in pain, and shortness of breath.The hcp stated the patient did not think his implant was working properly, and they needed someone to come check the pump.The hcp confirmed the pump was not alarming.The hcp stated she had already contacted the managing hcp, and they were not able to do anything for the patient at that point since the patient was visiting out of state.No further patient complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that there was no additional troubleshooting as there was no recovery and the device was still implanted.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via medwatch.The patient received only two warning alarms before the infusion pump went out.The pump stalled out after one of those alarms but took six hours to recover.Approximately 8 to 10 hours later the pump stalled again and never recovered.The physician was told by the manufacturer to turn the infusion pump off.This then stopped all therapy the patient was receiving for a very serious back injury.Additional information was received from a healthcare professional (hcp) via a company representative.The pump was replaced (b)(6) 2017 and will be returned to the manufacturer.

Manufacturer Narrative

Interrogation of the returned device revealed the pump had been programmed to deliver 4.0 mg/ml of morphine and 8.0 mg/ml of bupivacaine.As received, the pump was in stopped pump mode.Evaluation of implantable pump serial number (b)(4) revealed residue in the motor gear train and wearing on the upper shaft of gear number two.Analysis also identified damage to the motor o-ring.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) via a company representative.A motor stall was seen at initial interrogation.There were multiple motor stalls and recoveries.The pump has had intermittent motor stalls and the last motor stall had not recovered.It was unknown if the patient recently had magnetic resonance imaging (mri).It was confirmed there were no electromagnetic magnetic interference sources present.The reporter planned to follow up with the hcp.No further complications were reported.

• 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: 6683973
• MDR Text Key: 78956248
• Report Number: 3004209178-2017-14129
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2012
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR