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

Model Number 8637-20

Device Problems Aspiration Issue (2883); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Erythema (1840); Unspecified Infection (1930); Pain (1994); Seroma (2069); Swelling (2091); Fluid Discharge (2686)

Event Date 06/13/2017

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving morphine with an unknown dose and concentration via an implantable pump for non-malignant pain.It was reported via a clinical study the patient was diagnosed with a hardware infection at the pump pocket site.The patient presented on (b)(6) 2017 with incisional pain/swelling at the pump site.A seroma was noted and they were unable to aspirate/tried to aspirate but were unsuccessful on (b)(6) 2017.The pump was reprogrammed and the rate was increased on (b)(6) 2017.Examination on (b)(6) 2017 showed there was no signs/symptoms of infection.On (b)(6) 2017 it was reported the patient had/developed urinary tract infection symptoms, was seen by hcp, and labs were ordered.The results of the labs were unknown.On (b)(6) 2017 the patient reported having clear fluid leakage at the pump site noted at 10am (in the morning) per patient with abdominal pain only at the pump site (where pump was located).Examination on (b)(6) 2017 showed that there was a possible pump infection at the pump site, a broad spectrum of antibiotics were given, and the patient was admitted to the emergency room.Interventions included explanting (not replacing) the entire system on (b)(6) 2017 due to hardware infection.Examination on (b)(6) 2017 showed there was no signs/symptoms of infection.On (b)(6) 2017, the patient reported redness at the incision site with clear drainage.Medication, bactrim ds, was administered/prescribed on (b)(6) 2017.The event required in-patient or prolonged hospitalization.It was noted that the relationship of the event to the device or therapy was possible related, and the relationship of the event to the implant procedure was possibly related.The event was ongoing.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider (hcp) via a clinical study indicated the infection was confirmed.Laboratory testing of a wound culture on (b)(6)2017 was positive for infection.The exact cause of the infection/seroma was not noted.The outcome was 'unresolved at the time of study exit/death/study closure.'.

Manufacturer Narrative

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

Event Description

On 2017-oct-27, additional information was received from a healthcare professional (hcp) via a clinical study.It reported the patient/subject was exited from the study on (b)(6)2017.The reason for exit was all enrolled manufacturer products were inactive.No further complications were reported/anticipated.

• 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: 6941033
• MDR Text Key: 89230862
• Report Number: 3004209178-2017-21619
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Date Device Manufactured: 04/20/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 49