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

Model Number 8637-40

Device Problem Failure to Interrogate (1332)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2017

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

Information was received from a manufacturer's representative about a patient who was receiving dilaudid (unknown dose and concentration) via an implantable infusion pump for non-malignant pain and other chronic intract pain.It was reported on (b)(6) 2017 that the patient's is unable to be read despite the patient having been moved to a different area of the facility.It was stated they could not get telemetry even after using 3 programmers and moving the patient to different areas.It was confirmed the pump was not deep or tilted.The patient had not had any recent medical procedures such as radiation.The patient had recently fallen face first but did not fall on the pump.It was noted the patient had a significant increase in pain and flu like symptoms a week prior but the doctor stated they felt it was viral and was truly the flu and not withdrawal.The rep tried to interrogate the pump and got a "reposition programming head" message.Three different physician programmers were tried and the same message appeared.The orange light on the programming head blinked but never turned green.All possible interferences were removed and the patient was moved to different areas of the office but that did not work.The physician programmer batteries were taken out and put back in and tried again but that didn¿t work either.A lead apron was placed over the programming head but this did not work either.At the time of the report the issue had not been resolved.The rep stated they would try to interrogate the pump again in a day or two giving the pump time to reset.Surgical intervention did not occur and was not planned.

Manufacturer Narrative

Patient code (b)(4) was added and applies to the pump.

Event Description

Additional information received from a healthcare professional (hcp) on (b)(6) 2017 reported subjective (minimally) withdrawals without physical signs of withdrawal.It was noted that pump was attempted to be interrogated on (b)(6) 2017 by hcp and again on (b)(6) 2017 by hcp.Pump was replaced on (b)(6) 2017.The cause of the disrupted communication with the pump was not determined, but it was noted the pump will be set back to manufacturer for analysis.It was noted that the disrupted communication with the pump was resolved as the pump was replaced on (b)(6) 2017.It was noted that pump could not be interrogated, therefore no telemetry print outs were available.

Manufacturer Narrative

(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

Analysis of the pump found a hybrid failure with a high current drain in the pump.(b)(4).A supplemental regulatory report will be submitted when additional information is received.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

The pump was returned to the manufacturer for analysis.

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.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6289691
• MDR Text Key: 66154888
• Report Number: 3004209178-2017-02133
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• 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: 53 YR