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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395)

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

Event Date 11/01/2018

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 patient via a manufacturer¿s representative (rep) regarding the patient¿s drug infusion device.The drugs being delivered were 50 mg/ml dilaudid (hydromorphone) at 5 mg/day and 1,000 mcg/ml clonidine at 99 mcg/day.The reason for use was not reported.It was reported that they were unable to communicate with the pump using either 8840 programmer or (b)(6) clinician programmer.No prior known difficulties communicating prior to (b)(6) 2019.The cause of the event is undetermined.Environmental/external/patient factors that may have led or contributed to the issue included the patient stating the pump has been flipping since (b)(6) 2018.The have gained approximately 35 pounds since pump was replaced in (b)(6) 2018.Troubleshooting included attempting to interrogate pump with 8840 and clinician programmer on (b)(6) 2019.Actions that were taken to resolve the issue included the healthcare professional (hcp) to refer patient for pocket revision.Nothing scheduled at this time, but it was planned.The issue was not resolved at the time of the report and the patient status was listed as ¿alive ¿ no injury.¿ there were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider via the device manufacturer representative indicated that the cause of the pump flip and communication error were not determined.It was reported that the patient was referred to the surgeon for a pocket revision.No further complications have been reported.

• 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: 9010473
• MDR Text Key: 161490591
• Report Number: 3004209178-2019-17528
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169984226
• UDI-Public: 00643169984226
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Date Device Manufactured: 08/02/2018
• 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: 64 YR
• Patient Weight: 134