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

Model Number 8637-40

Device Problems Contamination (1120); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8551, serial#: unknown, product type: accessory.Other relevant device(s) are: product id: 8551, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via manufacturer representative regarding a patient who was receiving dilaudid (10 mg/ml, 0.480 mg/day) via intrathecal drug delivery pump for non-malignant pain and chronic low back pain.It was reported that the case was done with a contaminated instrument set.After the fact it was identified a filter was not in the lid of the set.There were no environmental/external/patient factors that may have led or contributed to the issue.No diagnostics/troubleshooting were performed.An explant was planned for (b)(6) 2018 at 1400.The patient status was 'alive - no injury.' the issue was not resolved.The explanted pump would be returned.There were no reported symptoms.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 via manufacturer representative.It was reported that the hcp denied needing the rep's presence for the explant.The hospital was going to keep the catheters and pump for their analysis, and would not return them to the manufacturer.No further complications were reported.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional.It was reported that the contamination was referring to the missing filter.One of two filters was missing from the surgical kit, not from a manufacturer's kit - the surgical instruments were lacking a filter.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: 8006371
• MDR Text Key: 125097390
• Report Number: 3004209178-2018-23944
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• 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: 11/12/2018
• Date Device Manufactured: 09/12/2018
• 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): Required Intervention
• Patient Age: 46 YR