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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Foreign Body Reaction (1868); Discomfort (2330); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative (rep) via a patient with an implantable neurostimulator (ins) for spinal pain.The rep was not with the patient during the report but the patient went to the emergency room (er) on (b)(6) 2017 and met with the rep on (b)(6) 2017.The patient reported having a shocking sensation that starts at the ins pocket site and radiates to their entire body especially in their back and at the ins pocket site.This was considered a sudden change in therapy/symptoms.The patient¿s ins is implanted on their left buttock.The patient did not have the stimulation turned on.The patient will report intermittent shocking and also indicated that random shocking will occur on the other side of the patient¿s body.The shocking sensation at the pocket site also occurred once when the patient charged their device.The rep indicated that the patient was crying and their back was arching back.The patient reported that the device is rejecting it and ¿eating a hole through them¿.The rep reported that the ins pocket site is healing normally, impedances are within normal limits, and palpating the pocket site does not re-produce the shocking sensation; it is just sore to the touch and not radiating.An x-ray has been done.The rep also reported that when the stimulation is turned on, it is covering their pain.The patient wants their device explanted.The rep stated that they would submit a follow up report.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacture representative (rep) on 2018-jan-30.The patient¿s weight being unknown was confirmed with the physician.It is unknown if the device will be returned for analysis.They were not at the explant.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacture representative (rep) on 2018-jan-10.The rep stated that it is unknown what cause the shocking at the implantable neurostimulator (ins) pocket site and in their entire body even with the ins off.The ins and leads were removed.There was no indication that the patient¿s body was rejecting the device or that it was eating a hole through them.It was unknown if the soreness at the pocket site had been resolved.The rep stated that the system would be returned for analysis.No further complications were reported/are anticipated.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7180036
• MDR Text Key: 96971487
• Report Number: 3004209178-2018-00584
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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,Followup,Followup
• Report Date: 02/09/2018

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: 06/28/2018
• 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: 12/27/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 01/10/2018; 01/30/2018
• Supplement Dates FDA Received: 01/30/2018; 02/09/2018
• Date Device Manufactured: 08/08/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 31 YR