MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problem Overheating of Device (1437)

Patient Problem Burning Sensation (2146)

Event Date 08/15/2016

Event Type  malfunction  

Event Description

The healthcare professional (hcp) of a clinical study reported that there was a heating issue with recharging.The patient reportedly lost around 70 pounds, a significant amount of which over the device, so the implantable neurostimulator got "really hot" when recharging that she had to stop.No actions were taken and the event was ongoing.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that the clinical diagnosis was heating issue at implantable neurostimulator (ins) site with recharging.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the health care provider (hcp) of a clinical study reporting that the device was interrogated on (b)(6) 2016, the patient was told to charge sooner and position charge was suspected.When the device was interrogated on (b)(6) 2016 and (b)(6) 2017, there was no mention in the doctor¿s note of any problems with the ins.The ins was working well.The outcome was reported as resolved without sequelae on (b)(6) 2017.No further complications were reported or anticipated.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5964533
• MDR Text Key: 55206476
• Report Number: 3004209178-2016-19305
• Device Sequence Number: 1
• Product Code: GZB
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2017

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 Expiration Date: 01/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/20/2016
• Supplement Dates Manufacturer Received: Not provided; 12/07/2016; 09/27/2017; 11/28/2017
• Supplement Dates FDA Received: 12/22/2016; 09/25/2017; 10/23/2017; 11/30/2017
• Date Device Manufactured: 02/28/2014
• 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 Age: 54 YR
• Patient Weight: 86