MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 97810

Device Problems Display or Visual Feedback Problem (1184); Failure to Interrogate (1332); Failure to Power Up (1476); Shipping Damage or Problem (1570); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: wr9220, serial#: (b)(4), product type: recharger; product id: wr9220, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: wr9220, serial/lot #: (b)(4), ubd:unknown , udi#:unknown ; product id: wr9220, serial/lot #: (b)(4), ubd:unknown , udi#:unknown see mfg report # 3004209178-2021-00839 for details pertaining to the patients second implanted system.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins).The rep reported that they tried to setup a wireless recharger for the patient, but the recharger just blinks really fast when docked and when the rep tried to turn on the recharger it would not turn on.The rep charged the device for 3 hours and they still can¿t turn it on.The rep said they tried docking the device on a different docking station as well but it won¿t turn on.No symptoms were reported.Additional information was received from a manufacturer representative (rep).The rep reported that both of patient¿s wireless rechargers did not work right out of the box at the hospital on doi.Caller stated they were told multiple times customer service would be overnighting patient new rechargers, but patient has not received.Caller reported due to rechargers not working patients¿ implants are dead and are not giving patient therapy.Caller declined any troubleshooting and stated they want all recharging equipment replaced (both rechargers, docks, and new wall chargers) because caller stated they can't determine what part isn't working.Caller was with patient and equipment on call and clarified issue with rechargers are that neither one of the rechargers charge and therefore cannot charge patients implants.Caller stated as soon as rechargers are removed from the dock "the lights go out".Caller also reported the rechargers will not sync with patient controller, stating "they are un-syncable".Caller stated one recharger came out of the box completely dead (recharger sn: (b)(4), dock sn: (b)(4)).Caller stated the other recharger does light up, but doesn't work (recharger sn: (b)(4), dock sn: (b)(4)).Caller clarified now both rechargers are dead and won't power on when pressing power button, both won't sync, and both won't charge.Caller inquired about shipping mode when patient receives replacement equipment.Patient services reviewed information with caller.Caller inquired if rechargers could be interfering if both rechargers are in use.Patient services reviewed emi considerations.Caller concerned that the recharging equipment may have been damaged during transit.Caller confirmed no visible damage to equipment.Caller may call back tomorrow when patient receives equipment for assistance setting up.Troubleshooting was unable to be performed as caller declined to troubleshoot.An email was sent to the repair departm ent.

Manufacturer Narrative

Continuation of d10: product id: wr9220, lot#/serial#: (b)(6), product type: recharger.Product id: wr9220, lot#/serial#: (b)(6), product type: recharger.Section d information references the main component of the system.Other relevant device(s) are: product id: wr9220, serial/lot #: (b)(6), ubd:unknown , udi#: unknown; product id: wr9220, serial/lot #: (b)(6), ubd:unknown, udi#: unknown.H.6 codes updated.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

Additional information was received from a manufacturer representative (rep).The rep reported that the recharger did not turn on at all and was completely depleted.They then charged it for 2 ½ hrs and it never turned on.They advised another manufacture representative said that the patient had been issued a new recharger and it was now working fine.The most likely cause of the ins depleting was the recharger was depleted upon package opening.The patient was issued a new recharger and the issue was confirmed resolved.The patient has been able to successfully charger their device to 100%.Mdr decision updated to not reportable.No additional supplemental reports are required unless additional information received indicates reportable event.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11177180
• MDR Text Key: 227028957
• Report Number: 3004209178-2021-00842
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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: 04/14/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; "SEE H10...."
• Patient Age: 53 YR