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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Ecchymosis (1818); Fever (1858); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Unspecified Infection (1930); Infiltration into Tissue (1931); Sepsis (2067); Septic Shock (2068); Swelling (2091); Complaint, Ill-Defined (2331); Sweating (2444); Abdominal Distention (2601); Test Result (2695)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a foreign healthcare professional (hcp) via a clinical study regarding a patient receiving intrathecal therapy.The drug, dose, and concentration were unknown.The indication for use was not reported.It was reported the patient developed a post-operative hematoma following a pump replacement on (b)(6) 2018.The patient was sweaty, developed hypotension, and experienced swelling around the pump with ecchymosis.The event resulted in in-patient hospitalization, prolongation of existing hospitalization, an emergency room visit, and an urgent care visit.An echography of the abdomen on (b)(6) 2018 confirmed a large hematoma around the pump on the right side.There was no intra-abdominal free fluid.The hematoma was removed, and surgical observation on (b)(6) 2018 revealed ¿active bleeding median cranial in the wound¿; coagulation of the bleeding in the wound occurred.The event resulted in a life-threatening illness or injury and resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.Conflicting information classified the hematoma removal as ¿medical or non-surgical intervention¿.X-rays of the thorax on (b)(6) 2018 showed no pleural fluid, no compactions, and no pneumothorax.The event was possibly related to the device/therapy and possibly related to the implant procedure.The event was ongoing.

Manufacturer Narrative

Test results refer to laboratory testing on 2018 (b)(6) showed a hemoglobin decrease, lower kidney function, and higher lactate.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a study.It was reported the patient went into hypovolemic shock.On 2018 (b)(6), vancomycin was administered, and the patient underwent a blood transfusion.Laboratory testing on 2018 (b)(6) showed a hemoglobin decrease, lower kidney function, and higher lactate.Echography of the abdominal wall on 2018 (b)(6) showed normal results.The patient was alert.The event resolved without sequelae on 2018 (b)(6).¿other etiology¿ noted the cause of the event was unknown, and it was later clarified the event was related to the implant procedure.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a study.It was reported the patient's height and weight were not measured.

Manufacturer Narrative

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

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a study.It was reported the event was "possibly" related to the implant procedure.

Manufacturer Narrative

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

Event Description

The patient was receiving baclofen (500 mcg/ml at 160.2086 mcg/day).

Manufacturer Narrative

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

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a study.It was reported that sepsis occurred on (b)(6) 2018.At urgency care, the patient developed a 'shock' image, probably based on a hypovolemic and septic component.On (b)(6) 2018, there was a respiratory focus with fever until 38.2°c, sputa and ¿decreased vag¿ on the right.An x-ray showed an infiltration right infrahilar.Piperacillin/ tazobactam + 1x vancomycin were administered for the sepsis on (b)(6) 2018.Tazocin-vancomycin, levophed, vasopressin and intravenous fluid suppletion were administered on-(b)(6) 2018.Oxygen therapy was also administered on (b)(6) 2018.Examination on (b)(6) 2018 showed a lightly bloated belly with palpable baclofen pump, limited subcutaneous crepitations, and no tension (pain).There was no blood loss.Device interrogation/device data on (b)(6) 2018 showed normal results.An echography of the abdomen on (b)(6) 2018 showed an important decrease of the subcutaneous hematoma around the pump.Active bleeding could not be excluded on this echo.

Manufacturer Narrative

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

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a study.It was reported that the cause of the event was unknown.

• 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: 7897912
• MDR Text Key: 121016394
• Report Number: 3004209178-2018-21232
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/21/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 09/21/2018; 09/24/2018; 10/11/2018; 11/06/2018; 11/06/2018; 12/20/2018
• Supplement Dates FDA Received: 09/24/2018; 09/27/2018; 10/30/2018; 11/08/2018; 11/08/2018; 12/21/2018
• Date Device Manufactured: 07/16/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 58 YR