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

Model Number 97714

Device Problems Overheating of Device (1437); Charging Problem (2892); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)

Patient Problems Swelling (2091); Burning Sensation (2146); Skin Inflammation (2443)

Event Date 12/30/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant product: product id: 37791, product type: recharger.(b)(4).

Event Description

Information was received from a consumer via a manufacturing representative (rep) regarding a patient who was implanted with a neuro stimulator for chronic low back pain and spinal pain.It was reported that there was a persistent thermometer icon.The patient was charging under blankets/pillows or near ambient heat source.The patient had tried multiple charging scenarios, including sitting up against something, lying on the floor, using the belt, etc.It was unknown if recharging in a well ventilated area resolved the issue.The patient got a blister over the implantable neurostimulator (ins) site from the charging heat.It was noted that the patient had a lead revision but the ins was not replaced and was currently using the same implantable neurostimulator recharger (insr) as before.The patient was told by the doctor she could start charging her ins immediately after the revision procedure even though the patient still had swelling over the ins today.Staples had just been removed today.Since the revision charging the ins area was getting very hot very quickly and the patient could only get 4 coupling boxes.The patient was seeing the thermometer screen on the in sr within 30 minutes of charging.The patient did not have these charging issues pre-revision.It was noted that the insr antenna was damaged.A healthcare professional (hcp) via a rep later reported that the patient was still having issues getting the battery to charge.There was swelling at the site of the battery.The patient was trying to charge through her clothes and it was not getting a good signal.No surgical intervention occurred and none was planned.It was noted that the issue was resolved at the time of the report.

• 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 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: 5413054
• MDR Text Key: 38132574
• Report Number: 3004209178-2016-01608
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• Date Device Manufactured: 06/02/2014
• 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: 00071 YR