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

Model Number 8637-40

Device Problem Application Program Problem (2880)

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

Event Date 01/14/2015

Event Type  malfunction  

Event Description

It was reported that the healthcare provider (hcp) refilled the patient's pump on the day of report and reprogrammed following the refill.The hcp also played the alarm test for the patient so they could hear the alarm sounds.On the printed session the hcp noted an empty reservoir alarm and low reservoir alarm had occurred.There was a message of "0.0mls" dispensed since last update was also on the printout.The low reservoir alarm was erroneous.Patient did not miss a refill.The alarm showed that they were occurring even though the reservoir volume was properly programmed to 40ml.While on the call, they reprogrammed the reservoir volume to 10ml and performed an update and then interrogated and updated the reservoir volume to 40ml (the correct volume).They confirmed the empty and low reservoir alarms were no longer there.There were no patient symptoms.The event recovered without permanent impairment.The pump system was delivering hydromorphone and bupivacaine.

Manufacturer Narrative

Concomitant: product id 8835, serial# (b)(4), product type programmer, patient.Product id 8780, serial# (b)(4), implanted: 2014-(b)(6), product type catheter.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id: 8835, serial# (b)(4), product type: programmer, patient.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.Product id: 8840, serial# unknown, product type: programmer, physician.Product id: 8870, serial# unknown, product type: software.(b)(4) no longer applies and instead (b)(4) applies.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 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: 4491601
• MDR Text Key: 5500715
• Report Number: 3004209178-2015-01937
• 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: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• 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: 12/06/2018
• Date Device Manufactured: 03/27/2014
• 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 Age: 00045 YR