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

Model Number 8637-20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Fatigue (1849); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Renal Failure (2041); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Cognitive Changes (2551)

Event Date 06/02/2018

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 healthcare provider (hcp) via a device manufacturer representative regarding a patient receiving infumorph (10 mg/ml at minimum rate) via an implantable infusion system.The patient's medical history included leg pain.It was reported that the patient was in the intensive care unit due to an unexplained 2-4 hours of confusion and disorientation.It was noted that the pump logs were read and nothing out of the norm was documented.The hospital was keeping the patient admitted until they were confident that she would be able to take care of herself.It was reported that the patient was kept overnight due to having a large drop in her blood pressure.It was noted that the patient had symptoms of tiredness and withdrawal due to a decrease in pump flow.It was reported that the patient woke up in the middle of the night disoriented, pulled out her intravenous therapy's (iv's) and would not cooperate with the staff.The hcp had difficulty getting iv's back in so opted to get a pickline put into the patient's chest.The issue was not resolved at the time of this report and the patient was alive with no injury.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a device manufacturer representative indicated that there was no explanation for the patient's reported complications.The issue was noted to be resolved.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer via a device manufacturer representative indicated that the patient's pump incision became infected which led to high blood pressure and "all kinds of things when wrong".One of the patient's kidneys failed and she ended up in the intensive care unit (icu) and then had double kidney failure which led to renal failure.It was reported that the patient was completely recovered and stable.The patient was referred to another healthcare provider (hcp) whom said the cause of the infection was due to the pump being implanted in the patients back and that the incision was incorrect.The patients weight at the time of the infection was provided.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

• 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: 7579181
• MDR Text Key: 110411857
• Report Number: 3004209178-2018-12880
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 04/14/2018
• 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: 67 YR
• Patient Weight: 82