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

Model Number 8637-40

Device Problems Kinked (1339); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient receiving dilaudid 3.0mg/ml for a total dose of 0.4996mg/day and bupivacaine 25mg/ml for a total dose of 4.164mg/day via an implantable pump for non-malignant pain.It was reported during a pump refill on (b)(6) 2018, device interrogation/device data revealed a reservoir volume discrepancy was no ted where the interrogated reservoir volume (irv) was 24.6ml and the actual aspirated volume (aav) was 32ml.No further diagnostics or interventions performed.There was no associated signs or symptoms reported.No action was taken.The outcome of the event wa s unresolved with no further actions planned.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 event date was (b)(6) 2018.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 provider via a clinical study reported the patient's baseline weight was (b)(6) lbs.It was noted the cause of the volume discrepancy was not determined.

Manufacturer Narrative

Product id (b)(4) lot# serial# (b)(4) implanted: (b)(6) 2015 explanted: product type catheter product id (b)(4) lot# serial# (b)(4) implanted: (b)(6) 2017 explanted: product type catheter : due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.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 cause of the catheter kink was not known.

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter; product id: 8784, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter, (b)(4).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, on (b)(6) 2018, the patient reported worsening pain at a scheduled pump refill visit.The patient's device was interrogated and noted a volume discrepancy in which the expected reservoir volume was 14.5ml and the actual reservoir volume was 34ml.The patient's chart was reviewed and noted a previous volume discrepancy at previous refill indicating a probable catheter kink.The device diagnosis was catheter kink and the clinical diagnosis was worsening pain.The patient was scheduled for a catheter revision.On (b)(6) 2018, the patient presented for revision and during the revision, a catheter kink at the connecting pin and anchor was noted.The entire catheter was replaced and returned to the manufacture.It was also noted there was scar tissue around the catheter connector and anchor.The issue resolved without sequelae on (b)(6) 2018.

• 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: 7445846
• MDR Text Key: 106069545
• Report Number: 3004209178-2018-08455
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• 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: 08/28/2018
• Date Device Manufactured: 09/03/2015
• 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: 58 YR
• Patient Weight: 93