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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Aspiration Issue (2883); Infusion or Flow Problem (2964)

Patient Problem Pain (1994)

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a device manufacturer representative regarding a patient who was receiving an unknown drug via an implantable infusion pump for non-malignant pain.It was reported that the patient complained of increased pain.The healthcare provider (hcp) was unable to aspirate the catheter at a dye study on (b)(6) 2018.A catheter revision was done.The catheter appeared to be occluded at the pocket.The pump segment was replaced.Then, the catheter was aspirated normally.The issue was resolved at the time of the report.The patient's status at the time of the report was alive - no injury.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 catheter portion would be returned, and the pump remained implanted.No further complications were reported.

Manufacturer Narrative

Continuation: product id 8780 lot# serial# (b)(4) implanted: 2017 (b)(6) explanted: product type catheter: analysis of the catheter found damage at the sc assembly.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: 7650283
• MDR Text Key: 112723241
• Report Number: 3004209178-2018-14642
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2017
• 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