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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Battery Problem (2885)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

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 the patient¿s implantable drug infusion device.The drug being delivered was dilaudid (hydromorphone) with an unknown dose and concentration.The reason for use was not reported.It was reported that there was a critical alarm and withdrawal.The pump was read by the physician and it is stalled on (b)(6) 2018.It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.No interventions/actions that were taken to resolve the issue at the time of the report.The issue was not resolved at the time of the report.No surgical intervention had occurred or been scheduled, but it was planned.The patient status was listed as ¿alive ¿ no injury.¿ there were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

It was reported that the cause of the motor stall was not yet determined.A dye study will be performed on 2018-(b)(6) to rule out catheter.The pump will be replaced soon after.The issue was not resolved at the time of the report.There were no further complications reported/anticipated.

Manufacturer Narrative

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 who reported that premature battery depletion occurred.The pump logs were read and showed the pump initially stalled and recovered on (b)(6)-2018; a second stall and recovery occurred on (b)(6) 2018; and the pump stalled a third time on (b)(6) -2018 and was still stalled on (b)(6) -2018.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.A dye study had been planned for today ((b)(6)-2018), but the patient had a uti (urinary tract infection).The issue was not resolved, and it was indicated that the hcp had no further information regarding the event.Surgical intervention was still planned, but no yet scheduled.The patient status was reported as ¿alive ¿ with injury¿ with the details of the injury being reported as withdrawal symptoms and the patient was now in severe pain from lack of therapy.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep on (b)(6) 2018.It was reported that replacement had not yet been scheduled.There were no further complications reported/anticipated.

Manufacturer Narrative

(b)(4) no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep on 2018-nov-07.It was reported that pump logs are not currently available.Logs did not indicate premature battery depletion but these stalls occurred before eri which is 5 months.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep on (b)(4) 2018.It was reported that the rep saw patient today ((b)(6) 2018) and the pump was alarming again after previously being silenced.It appeared that a short motor stall recovery occurred and then stalled again.They discussed with the physician and decided to permanently shut down the pump.It is to be replaced on (b)(6) 2018.The pump off password was given.There were no further complications reported/anticipated.

• 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: 8038709
• MDR Text Key: 126149926
• Report Number: 3004209178-2018-24683
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2013
• 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: 11/27/2018
• Date Device Manufactured: 04/18/2012
• 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: 65 YR