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

Model Number 97713

Device Problem Overheating of Device (1437)

Patient Problems Burning Sensation (2146); Numbness (2415)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

It was reported a week later that the recharger heated or warmed when charging the ins.This event was resolved by sending the patient a new recharger antenna.

Event Description

It was reported that during recharging the patient¿s antenna was heating and their skin was getting hot to the point where they had to remove their recharger antenna.Their skin would get ¿burning hot¿ and they felt like they were getting a burn or would get one if they did not stop charging.The patient experienced a warm sensation in or around their implantable neurostimulator (ins) pocket during recharging.The issue had been present for about a month and a half prior to the report.The patient¿s skin was kind of numb after the implant but they did not think that the warming issues during recharging had been present directly after implant.The patient had a doctor¿s appointment set up for the week after the report.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 37791, serial# unknown, product type: recharger; product id 97740, serial# (b)(4), product type: programmer, patient; product id 97754, serial# (b)(4), product type: recharger; product id 3587a, lot# lb1108, implanted: (b)(6) 2005, product type: lead; product id 3708360, serial# (b)(4), implanted: (b)(6) 2005, product type: extension.(b)(4).

Event Description

Upon return of the device, analysis found the complaint unverified.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4323017
• MDR Text Key: 5240520
• Report Number: 3004209178-2014-23782
• 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,Followup,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2015
• Date Device Manufactured: 11/20/2013
• 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: 00053 YR