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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problem Underdose (2542)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id :8780, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal unknown baclofen (concentration and dose unknown) via an implanted pump for an unknown indication.It was reported the preoperative and postoperative diagnosis were baclofen pump malfunction with catheter obstruction.The operation on (b)(6) 2018 included lumbar laminotomy at one level for removal and reinsertion of intrathecal baclofen pump catheter and with removal and reinsertion of pump with fluoroscopy.This was a patient with a history of having intrathecal baclofen pump now with difficulty in accessing the catheter access port (cap) and symptoms of drug underdosing.The patient was brought to the operating room and placed under anesthesia and placed in the lateral position with the left side up.An incision was carried out in the abdomen and one at the back to identify with a 15-blade.They dissected down with bovie to identify the pump.The pump was removed from the pocket and similarly in the posterior aspect of the back.They dissected down to the catheter and placed a self-retaining retractor.They disconnected the catheter from the pump and had no flow through the catheter.Then they disconnected it in the back area and got no flow.The old catheter was removed.A new catheter was then inserted with a small one level interspinous laminotomy done leksell ronguer and a kerrison rongeur down to ligamentum flavum and inserting the needle under direct vision with fluoroscopy.Fluoroscopy then used to insert the catheter cephalad.It was very difficult to get a good flowing cerebrospinal fluid (csf) stream despite repositioning of the catheter multiple times in the lower thoracic region.The catheter was definitively in, then it would stop draining and then it would drain again.Eventually, they inserted the catheter and got good flow, which was more consistent.It was tunneled to the abdomen and fixed in position.The same pump was placed in the pocket and programming the pump for priming bolus maintenance therapy.The pump was secured down with interrupted silk and the catheter with interrupted silk through the flange.The wound was closed with interrupted vicryl and the skin with staples.The patient tolerated the procedure well and was taken to the recovery room in stable condition.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) indicated there was not a pump malfunction, but a catheter malfunction.The reason for the pump procedure was the catheter malfunction.The cause of the catheter obstruction, difficulty aspirating the catheter access port (cap) and no flow through the catheter during the procedure was unable to be determined.It was noted the patient was approximately (b)(6) pounds.It was noted the ¿pump or patient doing well after catheter removed and reinserted.¿ no further complications were reported/anticipated or expected.

• 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: 7579715
• MDR Text Key: 110444834
• Report Number: 3004209178-2018-12898
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

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: 09/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 06/15/2018
• Date Device Manufactured: 03/20/2017
• 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: 25 YR
• Patient Weight: 45