MAUDE Adverse Event Report: NEURO - VILLALBA VECTRIS SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 977A260

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Respiratory Distress (2045); Heart Failure (2206)

Event Date 08/26/2016

Event Type  Injury  

Event Description

The healthcare professional (hcp) reported through a manufacturer representative that the patient experienced heart failure during lead implant.It was further reported the overweight and diabetic patient was lying in a ventral decubitus position when he wasn't able to breathe normally.The physician used an external defibrillator five times at the time of the event and the issue was resolved.There were no surgical interventions performed and it was unknown whether any were planned; the patient was alive with no injury at the time of report.The issue occurred during the procedure and the lead was implanted and out of service at the time of report.

Manufacturer Narrative

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

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5963188
• MDR Text Key: 55133350
• Report Number: 6000153-2016-00798
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2019
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Device Lot Number: 0209437803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• Date Device Manufactured: 03/23/2015
• 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
• Patient Outcome(s): Life Threatening