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 Abdominal Pain (1685); Erythema (1840); Unspecified Infection (1930); Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Type  Injury  

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient who was receiving an unknown medication via an implantable pump.Indication for use was spinal pain.The date of the event was unknown.It was reported the patient experienced a pump infection.It was unknown if the infection was related to the device.It was unknown how far the infection had tracked.It was planned to explant the pump on (b)(6) 2017 and possibly ligate the catheter.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional (hcp).It was unknown if the pump will be returned to the manufacturer.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional (hcp).The pump was out.The hcp would not be addressing for six months in regard to re-implanting the pump to make sure the infection was clear.

Manufacturer Narrative

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

Event Description

Information was received from a company representative.The explanted device will not be returned to the manufacturer.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional (hcp).It was reported that the patient first start experiencing the infection on (b)(6)2017.The infection was observed on (b)(6)2017 by medical professionals.Per patient, he noted redness since pump was placed in (b)(6) 2017.Wound opened on (b)(6)/2017 with drainage.It was reported that the patient had a symptom of pain over incision abdomen.Patient was taken to operating room for removal of pump on the same date.Patient was currently on iv antibiotic.Patient's weight at the time of the event was estimated to be (b)(6).Patient's medical history was reported to be chronic low back pain (lbp)/ sciatica, chronic obstructive pulmonary disease, high blood pressure (htn), crohn's and obstructive sleep apnea (osa).No further complications were 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: 6912919
• MDR Text Key: 88102340
• Report Number: 3004209178-2017-20576
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Date Device Manufactured: 06/30/2017
• 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: 51 YR
• Patient Weight: 118