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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON Back to Search Results
Model Number 97810
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Delayed Charge Time (2586); Charging Problem (2892); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Event Description
(b)(6) 2021 mpxr 873329 patlr rtg0518262 (con): information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that the patient stated they were having issues recharging the device and received a service code error of 1707.No interventions were done at this time.Additional information was received from the patient on (b)(6) 2021.They reported that they had an appointment on (b)(6), and the mdt rep connected the device, and the issue was resolved.No further complications were reported or anticipated at this time.Additional information was received from the patient on (b)(6) 2023.The reason for the call was to report that about a week ago, on saturday, when the patient went to charge their implant, when they connected it, it displayed a battery level of 30%, but it is typically at 60%.The patient said it took a much longer time to recharge their implant.When asked, the patient said she didn't make any adjustments to the settings and didn't turn stimulation off during the prior weeks.The patient then said that on last saturday they saw a red battery icon on the handset screen when trying to connect to recharge their implant.When asked, the patient clarified that on the screen they saw a red light by the ins battery level, and it showed 0%, and then the screen updated and said 60%.Reviewed recharging best practices and asked patients to consider implementing them next time.I also reviewed the option to schedule a device check at the hcp office to check the ins battery to help gather data as to why that one time displayed 30% at the start of the recharge session.
 
Manufacturer Narrative
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.
 
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Brand Name
INTERSTIM
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
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 Key18266807
MDR Text Key329729005
Report Number3004209178-2023-25176
Device Sequence Number1
Product Code EZW
UDI-Device Identifier00763000203849
UDI-Public00763000203849
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/14/2022
Device Model Number97810
Device Catalogue Number97810
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/04/2023
Initial Date FDA Received12/05/2023
Date Device Manufactured05/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age77 YR
Patient SexFemale
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