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

Model Number	8780
Medical Device Problem Codes	Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving morphine (0.5 mg/ml, dose 0.025 mg/day) via an implantable pump.It was reported that the pump had reached elective replacement indicator (eri) prior to the estimated eri date.Prior to being taken to the operation room (or), the physician performed a catheter access study and was unable to aspirate cerebrospinal fluid flow csf from the port.The patient was subsequently taken to the or and placed in a lateral position.The physician started by opening the pump pocket and dissecting out the pump and proximal segment.Once the pump was dissected out, he again attempted to aspirate from the catheter access port but was again unsuccessful.The pump was disconnected and discarded for planned replacement.The proximal pump segment was disconnected from the spinal segment at the collet.The physician then proceeded with another attempt to aspirate directly from the catheter, which was again unsuccessful.The physician then proceeded to open the lumbar incision.He dissected down to the catheter anchor and spliced the catheter below the anchor site.There was still no return of csf.The sutures at the anchor site were then removed, at which time it was noted that the catheter had been fractured above the anchor site.The remaining spinal segment was still implanted but inaccessible in the intrathecal space.The patient was on low dosing and has been doing well per the physician, he has opted not to replace the device at this time.He discussed this postoperatively with her husband.As noted above, there were no allegations regarding the pump or the pouch.The physician declined to return the proximal pump segment because the issue with the intrathecal catheter was in the spinal segment where it had fractured, which remained implanted but inaccessible in the intrathecal space.The patient¿s status was alive-no injury.The patient¿s medical history was asked but unknown.

• Brand Name: ASCENDA
• Common Device Name: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14848580
• Report Number: 3004209178-2022-08236
• Device Sequence Number: 2367424
• Product Code: LKK
• UDI-Device Identifier: 00643169202122
• UDI-Public: 00643169202122
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2017
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/28/2022
• Date Device Manufactured: 10/30/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 72 KG