MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8591-38
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) via a manufacturer representative (rep) regarding a catheter passer.It was reported that the handle of the catheter passer cracked when taking the handle off.No interventions were needed and the resolution was unknown.No surgical intervention occurred and none was planned.The patient's status was noted to be "alive-no injury".The patient's medical history included arm pain.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from healthcare professional (hcp) via a manufacturer's representative (rep).It was reported that the surgeon used the catheter passer to tunnel the leads for the stimulator, as opposed to the tunneler supplied in the lead kit.The cause of the cracked catheter passer was unknown.The surgeon said the catheter handle cracked/broke off as he was trying to remove it.The catheter passer was to be returned to the manufacturer for analysis.
Additional Manufacturer Narrative
The catheter passer was returned, and analysis found the device was used in a contraindicated manner.If information is provided in the future, a supplemental report will be issued.

• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7074310
• Report Number: 2021898-2017-00619
• Device Sequence Number: 1469844
• Product Code: LKK
• UDI-Device Identifier: 00673978226842
• UDI-Public: 00673978226842
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 8591-38
• Device Catalogue Number: 8591-38
• Device Lot Number: E36092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 12/11/2017; 03/08/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 01/08/2018; 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR