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

Model Number 8637-40

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Pain (1994); Discomfort (2330); Malaise (2359); Meningitis (2389); No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2018

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, product type: catheter.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving saline via an implantable infusion pump.The indication of use was failed back surgery syndrome and spinal pain.It was reported the patient passed away from bacterial meningitis that he got when he was getting the pump implanted.The lining of the patient's brain, spinal cord, and spinal fluid were all contaminated by the bacteria that flourished.He became ill and was transferred to a local hospital.The patient was transferred to hospice and passed away within hours of arrival.It was asked but unknown if autopsy records were available and the patient would be cremated in several days.It was noted that the patient had "many surgeries and stuff going on".The patient had never received any medication from the pump.Additional information was received from the healthcare provider (hcp).It was reported that they attempted to place the device on (b)(6) 2018, but were unable to achieve dural penetration despite multiple attempts and angling and elected to abort the procedure given the high level of attempts to reposition the needle.There was no additional information regarding the aborted procedure.The physician had nothing to report regarding the implant surgery other than they did not fill the pump after surgery with hydromorphone as anticipated and the pump remained with the sterile water that it came with.It was later reported that the patient reported right rib pain and lower abdominal discomfort after pump implant on (b)(6) 2018.No further complication was reported.

Manufacturer Narrative

(b)(4).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 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: 7484329
• MDR Text Key: 107269340
• Report Number: 3004209178-2018-10027
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

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: 07/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 05/07/2018
• Supplement Dates FDA Received: 05/08/2018
• Date Device Manufactured: 02/05/2018
• 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): Death; Hospitalization
• Patient Age: 75 YR