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

Model Number 8637-40

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Dyspnea (1816); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via a clinical study and a manufacturer representative (rep) regarding a patient receiving remodulin (unknown dose and concentration) via an implantable pump. It was reported there was a device malfunction where the expected residual volume was 9. 2 ml and the actual residual volume was 17. 9ml. The pump accuracy was 72% and the flow rate was outside the expected range. The patient reported no symptoms and there was no impact to the patient. There was no additional medical intervention required to prevent permanent injury or impairment and no action was taken. No assessment for product/therapy/procedure relatedness was performed. The patient's medical history included dyspnea / shortness of breath - on exertion, exercise intolerance, palpitations, orthopnea, congenital heart disease, hypertension, pulmonary hypertension (ph), syncope, due to unknown etiology, valve dysfunction, aortic, valve dysfunction, mitral, valve dysfunction, tricuspid, valve dysfunction, pulmonary, cor pulmonale, intrapulmonary shunting, renal dysfunction, not requiring dialysis, obesity, peripheral edema, sleep apnea, pneumonia, left upper lobe calcified granuloma, fibromyalgia, hysterectomy, back surgery, bacteremia (groshong catheter infection), dizziness, pre-syncope, jaw pain, headache, nausea, and chest pain. The event date was (b)(6) 2021. Additional information received from a rep indicated there was no resolution for this particular incident and no action was taken. In regards to the cause, it was noted it was unknown and was being investigated. No further complications were reported/anticipated.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11708115
• MDR Text Key: 247221287
• Report Number: 3004209178-2021-06503
• Device Sequence Number: 1
• Product Code: LKK
• 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

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial