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

Model Number 97714

Device Problems Break (1069); Migration or Expulsion of Device (1395); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Pain (1994); Respiratory Distress (2045); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

Section information references the main component of the system and other applicable components are: product id 97714 lot# serial# (b)(4) implanted: (b)(6) 2016 explanted: product type implantable neurostimulator product id 977a160 lot# serial# (b)(4).Implanted: (b)(6) 2016 explanted: product type lead product id 977a160 lot# serial# (b)(4).Implanted: (b)(6) 2016 explanted: product type lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A consumer reported via the manufacturer¿s representative (rep) reported they had increased pain at the battery site as well as a bruise, and it looked as if it was closer to the skin, but knew of no issues that could have led or contributed to this.It was noted the pain was there whether the device was on or off.The consumer¿s implanting physician recently closed their practice so their primary care physician (pcp) suggested they go to the emergency room (er) regarding the severe pain.The rep.Spoke with the consumer the morning of (b)(6) and at that time they were more comfortable and mentioned the er again.On the evening of (b)(6) the rep.Received a call from the consumer stating they were at the er and was being seen by neurosurgery.A ct scan was performed in the emergency room, which led to some question as the lead integrity, and the consumer being taken to the operating room.As a result the implant was explanted on (b)(6), but the leads were cut near the battery leaving the leads ¿partially implanted¿ and only the battery was removed resolving the issue.

Event Description

A family member of the patient reported that the patient¿s implantable neurostimulator (ins) was removed in (b)(6) 2016 due to shocking and burning in their back.The family member noted that the ins was removed on an emergency basis on the day that the patient reported the shocking sensation.The ins was not replaced at the time of the explant as the healthcare professional (hcp) and the patient were waiting for the analysis results to determine a plan for a new implant.Since the ins explant, the patient had not had pain relief and they were in severe pain.On (b)(6) 2017, it was reported that the patient had an appointment with a pain physician scheduled for (b)(6) 2017.

Manufacturer Narrative

Analysis of the implantable neurostimulator (serial number (b)(4)) found that it was functionally okay with insignificant anomalies.Analysis of the stimulation electrical leads (serial numbers (b)(4)) found that the lead body was cut through and the product was segmented.

Event Description

Additional information received from the consumer reported that the device was shocking and hot and moving outwards and pronounced so it was explanted by an er doctor.The patient noted once the device was explanted she felt better with the shocking and hot but her pain had returned.The indication for use was non-malignant pain.Further information received from the consumer reported that they had noticed the stimulator had moved up to just barely under the skin.The shocking got harder and longer and then it started getting hot inside and the pain was unbearable.After the device was explanted the patient stated she thought the implant had been helping her as she could at least stand up and now on the day of the report she could not do that and she couldn¿t breathe while standing.The patient mentioned she was in constant pain now and that the stimulator had helped her to walk.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient's husband on (b)(6) 2017.The patient's husband stated that they have not picked a healthcare professional (hcp) from the list that was sent to them and they were asked to email or call patient services once they chose a new hcp.No further complications were reported/are anticipated.

Event Description

Additional information was received from a patient on 2017-may-03.The patient reported that they are suffering and are in severe back pain 24/7.The patient stated that they need some help.No further complications were reported/are anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp)on (b)(6) 2017.The hcp stated that the patient¿s implantable neurostimulator (ins) was explanted but their leads were left implanted.The hcp did not know the reason for the explant.Additional information was received from a patient on (b)(6) 2017.The patient stated that they received their battery that was explanted.They are still in a lot of pain but noted that their stimulator did help them some because at least they could stand and walk for a few minutes.The patient indicated that they have a million other serious health issues that they are dealing with so the less stress the better.They finally have an appointment with a new back doctor.The patient would like to receive the analysis results of their explanted battery.They indicated that this happened in (b)(6) 2016.It started out shocking them and the more it shocked them the hotter it got.The patient has lots of pain, pain to the point where ¿you raise your back up off the table while you make sounds you did not know you were capable of making¿.The patient indicated that they were in the emergency room (er) when that happened and a doctor heard them and stayed and took the battery out which provided instant relief.The patient was notified that their hcp information was needed for the analysis results to be sent to.No further complications were reported/are anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.Patient provided their new back doctor and explanting doctor's information.It was reported that the explanting doctor just happened to be in the er, he was on his way out and was off.He heard patient's screams and turned around.He knew instantly what it was and called for the operating room.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Corrected information: no eval explain code.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

The manufacturer's representative (rep) returned the product and stated that they were aware of the complaint associated with the device.

• 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: 6221919
• MDR Text Key: 63847904
• Report Number: 3004209178-2017-00173
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR