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

Model Number 97714

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591); Charging Problem (2892)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 06/17/2016

Event Type  malfunction  

Event Description

Information was received from a manufacturer's representative (rep) regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported the patient was unable to charge.The patient only saw a reposition antenna screen with the implantable neurostimulator recharger (insr).Recharging best practices were reviewed, the antenna was positioned over the implantable neurostimulator (ins) and the patient attempted a recharge session, but got a reposition antenna screen.It was unclear if the patient was holding the insr appropriately.The patient was able to connect the patient programmer (pp) to the ins and saw a charge the ins screen.Each time patient services instructed the patient to use the insr, patient services was very clear and would confirm the device and location with the patient, but then after many attempts, it would turn out the patient was holding the pp so patient services did not know if the patient ever used the insr correctly.Repositioning the antenna did not resolve the issue.The patient could communicate with another external device.It was noted that an antenna locate feature was not attempted as the patient was having too much difficulty with basic insr use.The patient noted no bandages were present, but the ins site had not healed.Patient services recommended to the patient not to charge over an unhealed wound and to talk to her doctor.It was noted the patient would follow-up with the healthcare provider (hcp) to troubleshoot in person on how to charge.It was later noted by the patient there was pain at the ins site.It was noted that during the call, the patient was holding items against the ins site and the patient began saying that the ins site was burning.The patient noted that "something felt like it was on fire." at first the patient said this was being felt under ribs, but then the patient was talking about the ins site.This was when patient services confirmed with the patient that the ins site wound was not healed.

Event Description

The healthcare provider requested mri guidelines.The healthcare provider reported that the patient's ins never fully charges, and is charging too often.Additional information from the mri technician on (b)(6) 2016 indicated that the patient was attempting to turn their stimulation back on after their mri, but a "low ins battery" was displayed on the programmer.It was reviewed that the patient would need to recharge the battery before turning stimulation back on.It was reported that the patient has trouble recharging their device.It was suggested that the patient try and recharge their device as soon as possible and call patient services back for further assistance.No patient symptoms were reported.

Manufacturer Narrative

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

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5790601
• MDR Text Key: 49431088
• Report Number: 3004209178-2016-14108
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2016

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: 04/28/2017
• 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: 06/29/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided; 08/08/2016
• Supplement Dates FDA Received: 09/01/2016; 09/24/2017
• Date Device Manufactured: 06/01/2016
• 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: 67 YR