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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Rash (2033); Discomfort (2330); Complaint, Ill-Defined (2331); Post Operative Wound Infection (2446)

Event Date 09/16/2018

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 implantable drug infusion device.The drug being delivered was unknown.The reason for use was not reported.It was reported that the pump was explanted on (b)(6) 2018 because the patient was experiencing a skin rash around pump.There was stated to be possible infection or allergic reaction to titanium.There were no environmental/external/patient factors that may have led or contributed to the issue.Diagnostics/troubleshooting included specimens that were collected and sent for analysis for possible infection.The rep was in possession of the device to be returned to the manufacturer for analysis.It was unknown if a device was replaced by one of the same manufacturer.The issue was 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 rep on 2018-oct-25.It was reported that there was a red rash on the skin outlining the bottom of the pump.The infection or the allergic reaction were not yet confirmed.Samples for infection have been sent to a lab.Physician may recommend patient test for titanium allergy.The device was mailed on 2018-(b)(6) with no tracking number.There were no further complications reported/anticipated.

Manufacturer Narrative

The pump was returned, and analysis found no anomaly of the pump.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated the patient was receiving compounded morphine 1.0 mg/cc for a total dose of 0.3469 mg/day.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider via a clinical study reported the issue resolved without sequelae on (b)(6) 2019.It was noted the event date was corrected to (b)(6) 2018.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via clinical study indicated the patient's cultures were positive for pseudomonas.The clinical diagnosis was updated to wound infection.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 professional (hcp) via a clinical study indicated the patient was receiving compounded morphine with an unknown dose and concentration.It was reported on (b)(6) 2018 the patient experienced soreness and redness at the right lateral corner of the pump incision.Examination on (b)(6) 2018 confirmed redness at pump incisional site.It was noted the pump was not replaced.The outcome of the event was noted as ongoing.The clinical diagnosis was induration at right lateral corner of incision site.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The incisional site/device tract was pump pocket.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated possible infection was added to the clinical diagnosis.It was noted the system was removed secondary to infection.It was determined the patient had a slight infection versus an allergic reaction.No further complications were reported/anticipated.

Manufacturer Narrative

Event description updated to reflect the information received on 2018-dec-20.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study on 2018-dec-20.It was reported that the patient's infusion mode was set to flex dosing as of (b)(6) 2018.No further complications were reported or 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: 8006021
• MDR Text Key: 125036841
• Report Number: 3004209178-2018-23931
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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,Followup,Followup,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2017
• 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): Required Intervention
• Patient Age: 50 YR