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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

It was reported that a patient had issues with charging.It was stated that the patient was implanted on wednesday and the battery died ¿sometime friday night or saturday morning¿.It was stated that the patient woke up at 4am and was in a lot of pain, and her back ¿was absolutely killing¿ her.The patient stated she was scared because she had just undergone this surgery to have the stimulator put in and began to be concerned that the pain was due to ¿other factors¿.It was stated that the patient reported to her manufacturer¿s representative over the weekend that she was starting to "hurt a lot" and she was no longer feeling stimulation.The patient stated she was up to 4.1 and was not "feeling any tingles." it was noted that today she had an appointment with her hcp to remove the stitches.It was reported that the hcp said ¿everything was good¿ and that ¿this could be just from the surgery itself¿.It was noted that it was the same pain she had before the implant.It was stated that ¿nobody thought the battery had gone dead because they were expecting it to last for a week¿.It was stated that the manufacturer¿s representative ¿spread the signal out¿ and was now expecting to have to charge every other day.It was stated that through troubleshooting the manufacturer¿s representative had determined that the battery was ¿completely dead¿.It was stated that the manufacturer¿s representative walked the patient through how to recharge.It was noted that the patient ¿just can¿t sit that long¿ and tried to lie on her side to charge but could not keep a signal.It was further noted that the belt clip kept coming undone¿.It was noted that the manufacturer¿s representative gave the patient "sticky pads" which worked a lot better for her.It was stated that the manufacturer¿s representative got everything working again for the patient about 2 hours ago and she ¿felt the biggest difference¿.The patient stated that she got a really bad burning sensation and it took a while to calm down.It was reported that now it was starting to calm down.It was noted that this sensation was something she has had since before implant.The patient reported that she had stenosis ¿all the way through l5 and they fixed it at l1 and l2 but they said the surgery was not as good the lower you go so they recommended the device¿.The patient stated that the bone hurt and she got the burning sensation across her buttocks and the device helped with that.It was noted that the patient expressed dissatisfaction with an internal manufacturer¿s representative and felt the representative was ¿flippant and kind of laughing and wasn¿t listening to me¿.

Manufacturer Narrative

Concomitant medical products: 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 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: 3717244
• MDR Text Key: 4251362
• Report Number: 3004209178-2014-05394
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2014

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: 11/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 04/01/2014
• Date Device Manufactured: 01/08/2014
• 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: 00062 YR