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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Nonstandard Device (1420); Inappropriate or Unexpected Reset (2959)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015, information was received from a patient via a foreign healthcare professional (hcp) and manufacturer representative (rep) regarding a patient who was receiving compounded baclofen (1500mcg/ml) at 303 mcg/day (monday-friday) and 290.2 mcg/day (saturday-sunday) via an implantable pump programmed to flex dosing for an unknown indication.On an unknown date, the patient reported an alarm and came into the hospital.A review of the pump logs was initially impossible, but later interrogation showed the pump was in safe state.The patient's nurse was walked through getting the pump logs and the following logs were reported; reset, low battery reset and safe rate in use.The pump was reprogrammed as troubleshooting and the patient was sent home.The pump then had another reset, therefore, it was successfully replaced on (b)(6) 2015.The patient experienced no symptoms due to the event.The cause of the event could not be determined, but was suspected to be related to the field action for shorted feedthrough.Additional information has been requested regarding initial alarm and hospital visit date, but it was not available at the time of this report.

Manufacturer Narrative

Analysis of the pump (sn; (b)(4)) found a motor feedthru anomaly; shorting across insulator.

• 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: 5067020
• MDR Text Key: 25348048
• Report Number: 3004209178-2015-17651
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Remedial Action: Recall
• 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: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2011
• 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-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention