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

Model Number 8637

Device Problem Application Program Problem (2880)

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

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8840, product type: programmer, physician.(b)(4).

Event Description

The health care provider reported via the manufacturer representative that the patient's pump was filled on (b)(6) 2015.The pump was delivering 382.3 mcg/day of 2000 mcg/ml lioresal.No update was made to the dose or concentration.The pump was updated, and then a message was identified which showed a low and empty reservoir alarm occurred with the same timestamp on the date of the refill.The reservoir volume indicated that 20.0 ml were in the pump, and 0.0 ml of fluid was dispensed since the update.The low reservoir alarm volume was set at 2.0 ml.The refill interval was 0 days.It was noted that no alarm was heard at the refill.The nurse who performed the update was very methodical in the pump updates.Nothing out of the ordinary with the update process was identified.The most recent version of the data card (bbr01) was being used and was verified on (b)(6) 2015.It was noted that the low and empty reservoir alarm issue was resolved after an additional update of the pump.The refill interval updated from 0 days to 94 days.No patient symptoms were reported.The indication for use, the patient's medical history, and concomitant medications were unknown.The serial number of the clinician programmer used was requested.

Manufacturer Narrative

Product id 8840, serial# (b)(4); product type programmer, physician.

Event Description

Additional information was provided via the company representative (rep).The serial number of the clinician programmer was added.

Event Description

On 11-02-2015 additional information from the representative noted that normal programming, nothing different, had occurred.It was unknown if emi was present.However, programming occurred at the same hospital site that all patients were programmed with no difficulty.Should additional information be received a supplemental report will be filed.

Manufacturer Narrative

Product id: 8870, serial# unknown, product type: software.Product id: 8840, serial# (b)(4), product type: programmer, physician.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id 8870bbr01a, serial# (b)(4), product type: software.Product id 8840, serial# (b)(4), product type: programmer, physician.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): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5046678
• MDR Text Key: 25373327
• Report Number: 3004209178-2015-17082
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Followup,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2018
• Date Device Manufactured: 11/09/2012
• 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