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

Model Number 8637-20

Device Problem Difficult to Insert (1316)

Patient Problems Cerebrospinal Fluid Leakage (1772); Swelling (2091); Headache, Lumbar Puncture (2186)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, serial# unknown, product type: catheter.Product id: neu_unknown_cath, serial/lot #: unknown.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 device manufacturer representative regarding a patient receiving dilaudid(0.2 mg/day, 2 mg/ml) via an implantable infusion pump.The patient was a smoker.It was reported that the patient had developed headache approximately 3 weeks after pain pump was implanted.On (b)(6) 2018, it was noticed that he had some swelling at the base of the spinal scar.A binder was applied.A blood patch was done that seemed to help with the spinal headache.On (b)(6) 2018, headache returned and on (b)(6) 2018 headache got worse.In the er, it was noticed that he had a clear liquid coming out of the apex of the spinal scar.The healthcare provider (hcp) decided to take patient to surgery.When spinal scar was opened clear fluid was coming out from around the catheter insertion site.The healthcare provider (hcp) removed the spinal catheter up to the anchor, which was 25 cm of catheter from the intrathecal space.The anchor remained in place to be able to easily find catheter.The patient referred to neurosurgeon for repair of possible dural tear and reinsertion of the pump catheter into the intrathecal space.Incision was closed until neurosurgeon is able to see patient and schedule surgery.Time and day of surgery was unknown at this time.Pump was at minimum rate and the patient was admitted to hospital.Difficulty of inserting spinal needle at time of pain pump implant may have contributed to spinal leak.The issue was resolved and patient status was alive with no injury at the time of the report.No further complication was reported.

Manufacturer Narrative

Product id: neu_unknown_cath, serial# unknown, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a device manufacturer representative indicated that they went in and added the new spinal segment (8782- 42.4 cm).The caller required assistance with programming the catheter information.No further complications have been 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: 7898417
• MDR Text Key: 121047347
• Report Number: 3004209178-2018-21251
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2018
• Date Device Manufactured: 04/25/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR