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

Model Number 8637-40

Device Problem Failure to Interrogate (1332)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2017

Event Type  Injury  

Event Description

Information was received from a healthcare professional (hcp) and a manufacturer's representative (rep) regarding a patient receiving 2,000 mcg/ml baclofen at a dose of 115 mcg/day and 20 mg/ml morphine at a dose of 1.15 mg/day via an implantable infusion pump for intractable spasticity and multiple sclerosis.It was reported that the hcp had a telemetry problem with their clinician programmer.The hcp tried to interrogate the pump but was unable to complete telemetry.As troubleshooting the hcp tried different positions and removed electronics devices from the room, there were no more cell rooms in the room.The hcp tried unplugging the ultrasound machine and unplugging the power running to the bed which did not resolve the issue.The pump was not flipped and was refilled on (b)(6) 2017.Using a different clinician programmer did not resolve the issue.The clinician programmers that were used had been used successfully before in the same room to interrogate other pumps.No symptoms were reported.The hcp brought the patient outside and were still unable to read the pump.It was reported that on (b)(6) 2017 the rep talked to the hcp who stated that the patient used a personal therapy manager (ptm) programmer that also was not communicating successfully to the pump.The rep reported that the patient had not had any trauma to the pump or medical procedures that possibly the pump was exposed to.

Event Description

Additional information was received from a healthcare professional (hcp) on 2017-mar-06.It was reported that the plan was to have a local manufacturer's representative (rep) meet with the patient to see if the rep could interrogate the pump with a different programmer.The hcp was "very uncomfortable sitting on this, and was eager to have something clarified or fixed soon.".

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 a manufacturer's representative (rep) on 2017-mar-22.It was reported by the rep that they were still unable to establish telemetry with this pump using a clinician programmer as of (b)(6) 2017.They attempted using multiple programmers.Rep stated that "there was nothing wrong" with therapy and patient was doing fine medically as far as the rep knew.It was reviewed that the healthcare professional (hcp) should consider replacing the pump and the rep was to relay that information to the hcp.

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 a healthcare professional (hcp) on 2017-apr-03.It was reported that the patient's weight was (b)(6) lbs at the time of the event.

Event Description

Additional information was received from a manufacturer's representative (rep) on (b)(6) 2017.It was reported that the pump was going to be replaced on (b)(6) 2017.The pump was to be returned to the manufacturer for analysis.No further complications were expected or anticipated.

Manufacturer Narrative

Interrogation of implantable pump serial number (b)(4) revealed the device had been programmed to deliver 2,000 mcg/ml of lioresal at 114.9 mcg/day and 20 mg/ml of morphine at 1.149 mg/day via the simple continuous infusion mode.Evaluation of the device revealed the following: analysis identified a bit flip in the telemetry handler memory (circuit board) which resulted in inconsistent telemetry.Eval code-conclusion (b)(4) has been updated to eval code-conclusion (b)(4).This device issue is known and documented in the labeling per (b)(4) ¿ n¿vision clinician programmer with software synchromed ii infusion systems.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Corrected information: sex, date of birth.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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6376526
• MDR Text Key: 69017895
• Report Number: 3004209178-2017-04978
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 06/27/2017
• Supplement Dates FDA Received: 03/07/2017; 03/28/2017; 04/05/2017; 04/19/2017; 06/28/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2013
• 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
• Patient Age: 49 YR
• Patient Weight: 80