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

Model Number 97713

Device Problems Energy Output To Patient Tissue Incorrect (1209); Pocket Stimulation (1463); Device Operates Differently Than Expected (2913)

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

Event Date 12/19/2017

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 consumer regarding a patient with an implantable neurostimulator (ins) for chronic low back pain and spinal pain.It was reported that the patient was experiencing an issue with her therapy.The patient said that if she tried to bend over where the battery located and where the wires connect it is extremely painful.The patient said the stimulation has changed but noted that she is not getting shocked.The patient said it really hurts.The patient was redirected to their healthcare provider to discuss symptoms and to have the device checked.Additional information received from the patient reported that she had not heard from a representative yet and her primary care doctor did want to allow her to use their space to meet with a representative.The patient¿s managing physician was too far away.The patient was told to go to the emergency room.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (b)(4) 2018.It was reported the cause of the patient feeling stimulation and pain in their pocket was not determined.The ins was replaced the patient no longer feels the sensation when she bends over.The healthcare provider did not request examination of the ins.The issue seemed to be resolved.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturing representative (rep) and consumer.Information was reported that the patient complained of pain in her pocket site post-accident some months ago.She stated that she felt stimulation in the pocket even when the stimulation was turned off.The patient stated she bent over a while back and hurt her back.Since then she was feeling pain in her pocket site.The rep interrogated the battery and it was normal.Impedances were normal.The patient ins was explanted and replaced.The patient stated she does not feel the same pain in the pocket post-op.She is still in recovery.The issue was resolved.No further complications were reported.No additional patient symptoms were reported.

• 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: 7140093
• MDR Text Key: 95767545
• Report Number: 3004209178-2017-26512
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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: 06/25/2018

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: 03/14/2016
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 06/18/2018; 06/20/2018
• Supplement Dates FDA Received: 06/20/2018; 06/25/2018
• Date Device Manufactured: 02/26/2015
• 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: 67 YR
• Patient Weight: 91