MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ASCENDA; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8780
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Complaint, Ill-Defined (2331)
Date of Event	07/05/2019
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 consumer regarding a patient receiving unknown drug via an implanted pump.The indication for use was spinal pain.It was reported the patient's pump and catheter were electively replaced on (b)(6) 2019 and part of the catheter was left in the patient's body.A hematoma developed due to the removal and the patient had to go to the trauma center at the hospital where they did tests and blood work.The blood work showed no infection and the patient was referred back to physician that removed the device.The patient laid down and woke up sunday morning wet and was bleeding everywhere as the hematoma had opened up.The patient put some gauze on the hematoma and went to the hospital where they say for 3-4 hours.The patient then went to the different hospital where the physician put a new patch on the hematoma every day and said it would take months to resolve.The patient then went to california and went to the emergency room because they were feeling funny and had an ultrasound done.The tech said there is a part the is not going to dissolve and no general surgeon would remove it.The patient then went to mexico to visit their wife's family and laid down and woke up with blood.The patient went to the clinic and they did a culture that showed the patient had an infection.It was noted the tubing/blood capsule was left in the patient and it was currently infected.The patient was in the clinic for 2 days and was on antibiotics.The patient felt like the physician butchered them and they were in pain.

• Brand Name: ASCENDA
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 9008937
• Report Number: 3007566237-2019-01952
• Device Sequence Number: 2977130
• Product Code: LKK
• UDI-Device Identifier: 00613994555595
• UDI-Public: 00613994555595
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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: 11/02/2014
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR