MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC SYNCHROMED 2

Model Number 8637-40

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 01/04/2017

Event Type  Injury  

Event Description

Pain pump motor stalling. Patient is a (b)(6) who was transferred by ambulance to this facility due to malfunction of his pain pump. The patient endorses on friday he began having a lot of lower back pain and noticed his pain pump likely was not working. He states he continued to have pain through the weekend and decided to go to hospital for evaluation. It appears the patient had a pain pump placed in 2013 by dr. (b)(6) for chronic lower back pain. He states he's never had any problems in the past with his pump and denies any injuries or falls. The patient has extensive past medical history including cad, hyperlipidemia, hypertension, chf, anxiety and depression, gerd, in remission from lip and prostate cancer, sleep apnea and type 2 diabetes. He currently denies any fevers, recent illness, chest pain, shortness of breath, abdominal pain, diarrhea, dysuria, hematuria, hematochezia, loss of bowel or bladder function and no weakness of extremities. He reports he is very uncomfortable and is having a lot of pain currently after riding an ambulance. System found to be intact. I was able to aspirate a small amount of cerebrospinal fluid from the catheter.

• Brand Name: MEDTRONIC
• Type of Device: SYNCHROMED 2
• Manufacturer (Section D): MEDTRONIC; savannah GA 31404
• MDR Report Key: 6232491
• MDR Text Key: 64258650
• Report Number: MW5067095
• Device Sequence Number: 1
• Product Code: LKK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 01/05/2017 Patient Sequence Number: 1

Treatment

CATHETER 8784 NEURO - LOG411699; CATHETER 8784 NEURO 8784 MEDTRONIC (B)(4) ; MEDTRONIC, N/A 1 IMPLANTED ; N/A 1 IMPLANTED. ; PUMP 8637-40 SYNCHROMED MEDTRONIC (B)(4); PUMP 8637-40 SYNCHROMED MEDTRONIC - LOG411699