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

Model Number	8731SC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) regarding a patient.It was reported that the healthcare professional stated that the catheter was not connected to any "neuro battery" when it was initially placed into the patient.It was stated by the hcp that it was a shunt.It was removed due to an infection.The hcp reported the catheter was a revision from the one implanted on (b)(6) 2017, and then it was explanted on (b)(6) 2017.No further complications were anticipated.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the healthcare provider (hcp).It was reported that the patient first started experiencing the infection on (b)(6) 2017, per mr spine lumbar imaging.At the time of report the patient was on iv antibiotics and status-post (s/p) irrigation and debridement on (b)(6) 2017.The patient weighed (b)(6).It was reported that the shunt was removed on (b)(4) 2017 and discarded.No relevant medical history was provided.
Event or Problem Description
Additional information received on 2017-apr-12 from a healthcare professional reported the catheter was not connected to any "neuro pump".No further complications were reported/anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Common Device Name: 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
• MDR Report Key: 6432030
• Report Number: 3004209178-2017-06324
• Device Sequence Number: 13648991
• Product Code: LKK
• UDI-Device Identifier: 00643169496057
• UDI-Public: 00643169496057
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/21/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2018
• Device Model Number: 8731SC
• Device Catalogue Number: 8731SC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 04/12/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/06/2017; 04/21/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 136