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

Model Number 8637-40

Device Problems Intermittent Infusion (2341); Application Program Problem (2880)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/17/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2010, product type: catheter.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Information received from the patient via the manufacture representative.The patient was receiving morphine (15mg/ml at 3.011mg/day) via an implanted pump.The indication for use was noted as failed back surgery syndrome and spinal pain.The patient had experienced flu like symptoms and had gone through withdrawal.The physician stated the event was due to "motor stalls" however the logs did not show a motor stall.When the device was returned, the pump logs showed a motor stall had occurred on (b)(6) 2015 at 10:55 and recovered on (b)(6) 2015 at 11:41.It was unknown what let to the event.The pump logs showed estimated elective replacement indicator as 39 months.The issue was identified from the withdrawal symptoms the patient had experienced.No diagnostic/troubleshooting was performed.The pump was explanted and replaced on (b)(6) 2015.It was reported that the issue resolved at the time of report.It was also reported that the patient's status at the time of report was "alive-no injury.".

Manufacturer Narrative

Analysis of the pump (b)(4) revealed no anomaly found.

Manufacturer Narrative

The date of the motor stall/recovery in the event logs was updated from (b)(6) 2015 to the correct date of (b)(6) 2014.(b)(4).

Event Description

When the device was returned, the pump logs showed a motor stall had occurred on (b)(6) 2014 at 10:55 and recovered on (b)(6) 2014 at 11:41.

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): 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: 5062206
• MDR Text Key: 25213269
• Report Number: 3004209178-2015-17497
• 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,consum
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00045 YR