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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Difficult to Interrogate (1331); Pumping Stopped (1503)

Patient Problem Pain (1994)

Event Date 01/15/2014

Event Type  Injury  

Event Description

It was reported that, on (b)(6) the patient fell right on the pump and had a cervical spine fracture.He went to the emergency room that day and was admitted about four hours later.It was indicated that, when the pump was read, it showed a motor stall and a tube set message.It was believed that the stall occurred on (b)(6) and perhaps the fall had something to do with it.It was noted that the patient had not had an mri since the fall, only ct scans.At that time of report, the patient was in a lot of pain and was on patient-controlled analgesia (pca) with dilaudid.The device system was used to deliver clonidine, dilaudid, and marcaine.Five days later, it was reported that telemetry confirmed that a critical alarm was occurring due to the motor stall, but the alarm was not heard.It was noted that, when the reporter accessed the logs, there was difficulty keeping telemetry.The logs showed that the tube set message had occurred on (b)(6).At the time of report, the stall was constant and the pump had been set to minimum rate.It was indicated that the patient had suffered a heart attack and then fell.The patient was being treated by an intensive-care unit physician in the hospital and it was stated that they had not used cardioversion while treating the patient.Fifteen days later, it was reported that, one week prior to the fall, the patient was fine and was receiving effective therapy with no issues.It was unknown if the motor stall occurred prior to or after the fall; however, it was determined that the device and therapy had nothing to do with the heart attack.It was also stated that the cervical spine fracture had occurred when the patient fell and was not pre-existing.

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2010 product type: catheter.(b)(4).

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3619351
• MDR Text Key: 4159217
• Report Number: 3004209178-2014-02633
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2011
• 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: 01/17/2014
• Date Device Manufactured: 04/14/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 00062 YR