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

Model Number 97714

Device Problems Unintended Collision (1429); Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problems Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

It was reported that the patient had a warm sensation in or around the stimulator pocket during recharging.Her skin felt hot and would get red and sweaty.The patient felt like the warmth was coming from the stimulator itself and was not related to the recharger, however, it only occurred with recharging.This started to occur in august 2014 after the patient fell.The patient had fallen backwards on her stimulator site and had swelling.The patient stated a nurse had told her she had ripped 2 of the stitches at the stimulator site.The stimulation was unchanged and impedances were fine.It was also noted that the recharger showed the temperature message every time she charged, about 30-45 minutes into the session.The patient tried the antenna on her skin and thru material but it hadn¿t resolved.She had also tried using one spacer.Prior to the fall, the patient had charged twice without seeing a temperature message.Another spacer would be ordered for the patient.Additional information was requested regarding troubleshooting and the outcome.If received, a follow up report will be sent.

Manufacturer Narrative

Concomitant products: product id 97754, serial # (b)(4), implanted: explanted: product type recharger; product id 97754, serial # (b)(4), product type recharger; product id 97740, serial # (b)(4), product type programmer, patient; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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 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: 4613555
• MDR Text Key: 5656810
• Report Number: 3004209178-2015-04944
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2015
• Date Device Manufactured: 02/27/2014
• 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: 00032 YR