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

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Application Program Problem (2880); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2017

Event Type  malfunction  

Manufacturer Narrative

References the main component of the device system; the other relevant components include: product id: neu_ptm_prog, serial# unknown, product type: programmer, patient.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 foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving hydromorphone 10.0 mg/ml at 0.500 mg/day and clonidine 100.0 mcg/ml at 5.00 mcg/day via intrathecal drug delivery pump for an unknown indication of use.It was reported that there were multiple bolus request (88) and denials (89) that occurred.No further information was reported and there were no symptoms reported.Additional information received.It was previously noted that the drug in the pump was hydromorphone and additional information indicates that the correct drug is hydromorphone.The serial number of the patient¿s personal therapy manager (ptm) was not known when asked.It was reported that the manufacturer representative was not aware of a bolus lockouts and there was no allegation of any bolus lockouts.There was no patient involvement in the event.The suspected cause for the bolus lockouts was patient error.There were no diagnostics/troubleshooting that was performed and no actions/interventions were taken.There were no reported complications.Additional information was received from a foreign consumer via a manufacturer¿s representative.The pump was newly implanted, but the patient was complaining of not being able to get the ptm doses at the right time.He knew about the 24-hour rolling adjustment, but what he said did not match what the hcp would expect the pump to do.The patient was not convinced the pump control function was working correctly.An example of times of ¿mogul application¿ was given.Wednesday, (b)(6) 2017 : 1st: 4:47 am, 2nd: 10:25 am, 3rd: 12:33 pm, 4th: 3:18 pm, 5th: 4:32 pm, 6th: 9:17 pm, 7th: 10:20 pm.Thursday, (b)(6) 2017 : 1st: 1:15 am, 2nd: 5:50 am, 3rd: 7:19 am, 4th: 8:22 am, 5th: 9:38 am, 6th: 6:02 pm, 7th: 10:00 pm.The patient stated they were restricted to 7 ¿moguls¿ per day for a 24-hour period from 12 midnight to 12 midnight.They understood that they should be similarly restricted on a rolling 24-hour bolus.They stated that from the given example of bolus applications, 11 successful ¿mogul applications¿ were allowed from wednesday, (b)(6) 2017 at 10:25 am, to thursday, (b)(6) 2017 at 10:25 am.They had noticed this happening on a number of other occasions, and they have also been refused ¿mogul applications¿ sometimes when they could see no reason why.They stated they had lost confidence with the pump.No further complications were reported or anticipated.

Manufacturer Narrative

The previously reported (b)(4) no longer applies to this event.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

On 2017-apr-04, additional information was received from a foreign manufacturer representative (rep).Additional information reported the patient was using a personal therapy manager (ptm) and was not getting "the therapy they need".The rep was looking for a better way to program the pump.

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.It was reported that the cause of the patient receiving more than their 7 allotted boluses in the 24-hour rolling period was not determined.No further complications were reported and/or anticipated.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6456621
• MDR Text Key: 71826898
• Report Number: 3004209178-2017-06960
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2017
• Date Device Manufactured: 01/20/2016
• 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 Age: 69 YR