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

Model Number 97712

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37761, serial#: (b)(4), product type: recharger.Product id: 97754, serial#: (b)(4), product type: recharger.Product id: 37712, serial#: (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id: 37761, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.It was reported that the patient was unable to charge their implant and it the implant was believed to be overdischarged.The rep could not connect with the clinician programmer.The patient had last charged (b)(6) 2018 because the patient's trip went longer than expected.They were unable to charge during that time.There was poor communication and the patient was unable to communicate with another external device.The patient's recharger was stuck/frozen on the screen telling the patient to place the antenna over the implant.Several manual resets did not resolve the issue.It was also reported that the desktop charger connector pin was bent/broken and it had a hard time recharging.It took forever to recharge the recharger because of it.No symptoms were reported.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Product id 37761 lot# serial# (b)(4) implanted: explanted: product type recharger product id 97754 lot# serial# (b)(4) implanted: explanted: product type recharger product id 37712 lot# serial# (b)(4) implanted: (b)(4) 2013 explanted: product type implantable neurostimulator: analysis of the desktop charger ((b)(4)) found the cable assembly connector pins were broken: conclusion code (b)(4) applies to the ins and conclusion code (b)(4), method, and results applies to the desktop charger.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received and it was reported that and new desktop charger and recharger were requested.Then the ins was able to be manually reset and began charging.No symptoms were reported.No further complications were reported or anticipated.

Manufacturer Narrative

Continuation of concomitant medical products: product id: 37761, serial# (b)(4), product type: recharger.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 37712, serial# (b)(4), implanted: (b)(6) 2013.Product type: implantable neurostimulator.Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.Fdc 67, fdm 4114, fdr 3221 apply to the ins (serial # (b)(4)) and fdc 67, fdm 10, and fdr 180 and 426 apply to the desktop charger (serial # (b)(4)).Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7567429
• MDR Text Key: 110045312
• Report Number: 3004209178-2018-12552
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 78