MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN LEAD; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_UNKNOWN_LEAD

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, product type: lead.This report is for the "second case" of brand new leads that were being placed that were fractured during stage 1.Implants.Please see manufacturer report #3007566237-2015-02421 for the first case.(b)(4).

Event Description

The manufacturer representative reported that there had been 1 or 2 cases of brand new leads that were being placed that were fractured during stage 1 implants.The manufacturer representative believed that damage could have been done from the depth stop gauge being seated too high because of possible technique issue.The manufacturer representative did not have any additional information regarding the 1-2 events as the hcp just mentioned it to him in passing.This event occurred intraoperatively.The indications for use (ifus) were unknown.

• Brand Name: UNKNOWN LEAD
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5036821
• MDR Text Key: 25145961
• Report Number: 3007566237-2015-02425
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/06/2015

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
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• 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