MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97714

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Electric Shock (2554); Insufficient Information (4580)

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 and a manufacturer representative regarding a patient who was implanted with a neurostimulator for spinal pain and chronic low back pain.It was reported that the patient was experiencing poor communication using the external antenna.The patient was able to communicate with the recharger and had successfully charged a day before.The patient checked that their antenna was secure and attempted to interrogate but could not.The patient tried interrogating using the programmer directly and was able to.The patient was seen by a rep for a routine programming check in (b)(6) 2017.The patient was issued a new programmer.Additional information was received from a consumer regarding the patient on (b)(6) 2017.It was reported that the programmer antenna was replaced but they were still having issues with connecting to their implant.The patient reported it occasionally worked.Additional information was received from a manufacturer representative regarding the patient on (b)(6) 2017.It was reported that there was a poor communication screen on the patient programmer (pp).The rep stated they are troubleshooting the issue with the pp antenna getting poor communication which has been ongoing since the last day of service.Additional information was received from a consumer regarding the patient on (b)(6) 2018.The patient noted that she had her patient programmer replaced 5 times since the device was put in on (b)(6) 2014.The patient programmer antenna was replace 5-6 times, and the recharger antenna was replaced about 3 times.It was reported that the battery be came defective around (b)(6) 2016/(b)(6) 2017.In (b)(6) 2017, they came to the conclusion that the battery was defective.The implantable neurostimulator was not connecting with the patient programmer.Sometimes it would connect, and sometimes it wouldn¿t.The patient noted that it had never responded with the antenna attached to the patient programmer.The patient never let her battery go dead.Her health care provider stressed never to let the implantable neurostimulator die, so she never let it die even one time.In addition, the device started to shock her even when she had it on 0 volts starting in (b)(6) 2016.The numbers on the device did not change, but the electricity in the device would go up to the point that she could barely walk to get back to the remote.The patient noted that it was like being electrocuted.This happened four times to her.The health care provider had told her to keep it off since it was unpredictable.Additionally, the patient was rear ended by a commercial vehicle while at a red light.She had neck issues before, but it was exacerbated, and she had horrible pain which had been occurring since prior to implant.The patient had to go through a revision surgery for a new battery on (b)(6) 2018.There were no further complications reported or anticipated.

Manufacturer Narrative

Correction section d: it was determined that previously submitted regulatory report had an incorrect device information.The correct device associated with this complaint is (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

Pt said they had a claim for a defective battery that got replaced.Pt was looking to get assistance from a rep to get the forms filled out.Pt said when their device was implanted, it worked up until 2017 and then became a problem in 2017.Pt said they had met with several reps to get it reprogrammed but then the ins was malfunctioning and "pretty much electrocuted" them 5 times.Pt said their rep had decided the ins was defective in september of 2017.Pt said they were so sick and depressed and now want assistance filling out the paperwork for the defective ins claim.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 7383767
• MDR Text Key: 103917820
• Report Number: 3004209178-2018-06059
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

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: 12/14/2014
• 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: 03/23/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 04/13/2022
• Date Device Manufactured: 01/20/2014
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female