MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problems Overheating of Device (1437); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Burn(s) (1757); Skin Inflammation (2443)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient reported through a legal representative that they experienced burning at their device site.It was further reported that it had ¿burned his skin and caused blistering.¿ the ¿date of defect¿ was noted as approximately (b)(6).It was noted that a removal date for the device was ¿n/a.¿ no further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a legal representative of the patient reporting that for the first year and a half the device functioned properly.However, around (b)(6) 2017, the patient began experiencing problems with his device.The device would get so hot at the battery site that it would burn the patient¿s skin and caused blistering.Due to the severe heat generated by the device¿s battery, the patient was no longer able to use their device.The patient was told that the battery and leads must both be removed, otherwise an mri, if ever needed, would ¿cook¿ their spine.When the patient discussed removing the device and leads, the doctor said, ¿i¿ll take out the leads but if you get paralyzed, it¿s on you.¿ the unit was dormant and remains in the patient¿s body.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7030496
• MDR Text Key: 92905905
• Report Number: 3007566237-2017-04826
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2017
• 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