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

Model Number 8637-40

Device Problems Filling Problem (1233); Protective Measures Problem (3015)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2018

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 regarding a patient receiving hydromorphone, bupivacaine and baclofen, dose and concentrations not reported, via an implantable pump.The indications for use were not reported.On (b)(6) 2018 the healthcare provider reported they were filling the pump under fluoro in the or (operating room) and was able to aspirate the pump without difficulty but was only able to fill the pump half full.The healthcare provider then attempted to aspirate the contents of the reservoir and now it was locked.It was confirmed proper needle orientation and troubleshooting options were reviewed.There were no patient symptoms and no further complications were reported.

Event Description

Additional information was received from the consumer who reported that their pump was replaced because the healthcare provider was unable to fill it.Per the patient it was gradually getting harder to fill and then eventually the physician was able to remove the medication but not fill the reservoir.

Manufacturer Narrative

The initial mdr was filed as mfr report # 3007566237.Additional review indicated the correct manufacturing site is 3004209178.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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• MDR Report Key: 7451112
• MDR Text Key: 106180278
• Report Number: 3007566237-2018-01197
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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: 08/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR