MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37702

Device Problems Failure to Deliver Energy (1211); Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Information (3190)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018 mpxr (b)(4) (for, rep, hcp): information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for unknown indications for use.There was a loss of stimulation.The patient was scheduled for a lead replacement, and during outpatient follow-up interrogation showed all "x's" on electrodes and an ins voltage of 0.0.Impedance measurement was performed at 0.25 v.Another impedance check was planned for during the replacement surgery at higher voltages, which "did not show other than mentioned outcome".There were no known contributing factors.No intervention had been taken yet, and the event was unresolved.The patient was scheduled for surgery the week after this report,and it was unknown if explant/replacement would take place.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received reported that the patient¿s lead was not replaced.No further complications were reported.

Manufacturer Narrative

Analysis of the returned ins (serial(b)(4)) found a software or firmware anomaly with an unknown cause.Visual inspection of the ins did not reveal any significant anomalies.The connector module was scratched, and foreign material was observed under the cover.Foreign material was also visible in the connector port.The access hole adhesive was visibly cut and breached.The grommet was visibly ok.The setscrew was backed out too far.The shield/can was visibly scratched and dented.Initial examination confirmed a no output condition.Telemetry tested ok.An impedance test in saline was done, and all electrode pairs measured "xxx".The ins was sent for destructive analysis of the battery.X-ray inspection of the ins did not reveal any anomaly.Impedance was tested again in a saline solution, and all impedance values were nominal.Output was tested, and therapy functionality was confirmed with no anomalies uncovered.Destructive analysis of the battery hybrid did not show any anomaly.The device output restored between the time it was put through a series of defined and qualified automated functional tests when it was first received and analyzed, and when it was received and analyzed as part of the destructive analysis.No physical hybrid anomaly was observed, so a firmware/software issue was suspected.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Fdc 4315 applies to the implantable neurostimulator, fdc 11 no longer applies.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: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud MN 1131 ; CH 1131
• MDR Report Key: 7953613
• MDR Text Key: 123358213
• Report Number: 3007566237-2018-03000
• Device Sequence Number: 1
• Product Code: LGW
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2019

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: 11/28/2014
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 11/01/2018; 02/05/2019; 05/09/2019
• Supplement Dates FDA Received: 11/15/2018; 02/19/2019; 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention