MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN NEUROMODULATION LEAD; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that the hcp (healthcare provider) tested impedances intraoperative today at new lead and ins implant for a patient.Intraoperative, the impedances were approximately 440 ohms.Then, when the patient was in recovery, the impedances were down around 250ohms.Hcp replaced the leads and the impedances went back to around 440ohms.The event resolved by replacing the leads.Additional information has been requested but was not available as of the date of this report.A follow-up report will be made if additional information becomes available.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial# unknown, product type: lead.Product id: neu_unknown_lead, serial# unknown, product type: lead.(b)(4).

• Brand Name: UNKNOWN NEUROMODULATION LEAD
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4334646
• MDR Text Key: 5140859
• Report Number: 3007566237-2014-03641
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/16/2014
• 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