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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Failure to Interrogate (1332); Pumping Stopped (1503); Intermittent Infusion (2341); Device Operates Differently Than Expected (2913)

Patient Problems Itching Sensation (1943); Therapeutic Response, Decreased (2271)

Event Date 05/01/2016

Event Type  malfunction  

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 healthcare provider via a manufacturer representative regarding a (b)(6) male patient receiving baclofen (concentration 500) via an implantable pump for intractable spasticity.The patient complained of itching and a lack of efficacy which began in (b)(6) of 2016.Interrogation of the pump on (b)(6) 2016 showed that a motor stall occurred.The healthcare provider increased the patient¿s dose and ¿got it started again.¿ on (b)(6) 2016, the manufacturer representative was unable to get the pump to communicate with the physician programmer.It would get 50-75% of the way through interrogation and then get stuck there indefinitely.Three different programmers were tried.The reporter was not aware of any environmental, external, or patient factors that may have led or contributed to the issue.The patient was being scheduled for a pump replacement, unless a non-surgical solution was found.The patient¿s status was alive with no injury.

Event Description

Additional information received from a company representative reported a telemetry issue with a pump that was a little over a year old.It was believed there had been issues created and that the pump was "having problems with delivering medication".The patient was seen (b)(6) 2016 and attempted telemetry but it would only get half way to 3/4 through and it would never successfully telemetry.The pump was shallow and tight in the pump pocket, so it was not believed that the pump was flipped.The representative indicated they would try to successfully telemetry the pump on (b)(6) 2016.

Manufacturer Narrative

Review of the additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a serious injury.(b)(4).

Event Description

Additional information was received from a manufacturer representative.It was reported that the pump had stalled, and they thought that the pump was dead because they could not interrogate it.The representative was instructed to move the patient from the room or to use an x-ray shield to block possible interference from the lights.Once the patient was removed from the room, they were able to interrogate without issue and saw that the pump was not stalled.The pump was not replaced.It was indicated that the pump contained baclofen.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5685763
• MDR Text Key: 46114880
• Report Number: 3004209178-2016-10504
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• 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: 06/28/2016
• Date Device Manufactured: 11/10/2014
• 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: 61 YR
• Patient Weight: 79