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

Model Number 8637-40

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Complaint, Ill-Defined (2331); Sedation (2368); Loss of consciousness (2418)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving ga blofen (2000mg/ml at an unknown dose) via intrathecal drug delivery pump.The indication for use was noted as intractable spasticity.It was reported that the patient went in for a normal refill on (b)(6) 2018.There was a pocket fill and it appeared that 35ml of drug was filled into the subcutaneous tissue.The manufacturer representative was not sure if a manufacturer kit was used for the refill.The patient went to the intensive care unit (icu) the night of (b)(6) 2018.The patient was recovering from the event as of (b)(6) 2018.They were being monitored.There were no further complications reported at this time.

Manufacturer Narrative

Patient code (b)(4) no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a hcp.It was reported that the patient had become unresponsive during the event.She was intubated and sedated for 3 days.She remained hospitalized for a week while her dose was adjusted after her pump was refilled.There were no further complications reported at this time.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7342133
• MDR Text Key: 102510351
• Report Number: 3004209178-2018-05097
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,health
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 04/05/2018
• Date Device Manufactured: 11/20/2016
• 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-1060-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 23 YR