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

Model Number 97714

Device Problems Battery Problem (2885); Charging Problem (2892); Connection Problem (2900); Insufficient Information (3190)

Patient Problems Fall (1848); Pain (1994); Seizures (2063); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37761, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(4).Outcomes to adverse event: marked other for seizures reported.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 non-malignant pain.It was reported that the desktop charger (dtc) had a bent connector pin.The patient stated their ins was for 'pain but there is something going on neurologically because i've so much nerve damage to my face and my other nerves, cranial nerve.But what happens is when it (ins) stops working, it increases the pain, and unfortunately my body's response to the pain is actually having seizures, or drop episodes where i'm awake, but i can't move.I fall down to the ground and i can't move.It is seizure like and it's pretty serious for me'.The patient confirmed that because the dtc broke they were having these symptoms.A replacement dtc was sent to the patient.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Information was received from a patient.The patient reported that their connector pin is bent, and they can't recharge.They stated that they need the recharger because their implantable neurostimulator (ins) is dead and they have seizures because they don't have it.The patient mentioned that they have complex pain syndrome that involved retractable migraines, and part of that causes them to have episodes of seizures and drop attacks.Troubleshooting could not be done at the time of the report as the patient did not have access to the product.The patient mentioned that they would be calling back.No further complications were reported or anticipated.

Manufacturer Narrative

Analysis on the desktop charger (serial# (b)(4)) determined there was a bent connector pin.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.

• 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
• MDR Report Key: 9182277
• MDR Text Key: 164130638
• Report Number: 3004209178-2019-19305
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2019

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: 07/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 10/23/2019; 12/23/2019
• Supplement Dates FDA Received: 11/14/2019; 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR