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

Model Number 8637-40

Device Problems Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 01/05/2018

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 professional via a manufacturer representative regarding a patient receiving an unknown d rug with an unknown dose and concentration via an implantable pump for intractable spasticity.It was reported the patient was going to get explanted today ((b)(6) 2018) because the patient developed a wound over the pump site.They felt this was because the patient had lost at least 5 pounds, and that because of the weight loss, the pump became a site for a pressure ulcer to form.It was later reported that the patient first experienced the ulcer over the pump on (b)(6) 2018.The cause of the weight loss was noted to be due to a decreased appetite and multiple surgeries.It was unknown if the ulcer over the pump was resolved as the pump was removed.The patient's weight at time of discharge was (b)(6).No further complications were reported/anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative.It was reported that reason for infusion device removal was the battery was depleted.There were no further complications reported at this time.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the implantable pump (serial # (b)(4)) identified no anomalies.The returned device passed all functional testing in the laboratory.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: 7241984
• MDR Text Key: 99048076
• Report Number: 3004209178-2018-02100
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• 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): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 16