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

Model Number 97810

Device Problems Display or Visual Feedback Problem (1184); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis of the ins 97810 (s/n: (b)(4)) determined that the service life of the implantable neurostimulator (ins) was started prematurely.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) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.The rep reported that an account received an ins on (b)(6) 2020 but when the caller interrogated the ins it was only 10% charged.The caller charged the ins to 40% and then they received a por message.The caller tapped ok to advance into the session and there was already patient information entered and it had patient's dob as (b)(6) 2020.The caller speculated the ins may have not been used for a case and sent back, then shipped out again to another customer.The caller looked up the patient but didn't see them registered and assumed that (b)(6) 2020 may have been the date of the original case in which the ins wasn't used.Troubleshooting was not required.Technical services (ts) reviewed that the ins was likely okay to use given that the ins charged fine and devices can incur pors, but given the suspicious circumstances, the caller should return ins for analysis.Ts emailed caller with case number to use for customer service purposes.Ts changed case priority to critical in case of an out of box issue.There was no patient involvement in this event.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11922754
• MDR Text Key: 267101495
• Report Number: 3004209178-2021-08704
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2021

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 Date: 04/14/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1