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

Model Number 3058

Device Problems Loss of Power (1475); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was implanted with a neurostimulator (ins) urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.The hcp reported that she did not talk to this patient directly, but her notes stated that the patient reported that the "battery is out".The hcp did not know if this was the implanted battery or the remote battery.The hcp requested compatibility guidelines for an mri.The hcp stated that the mri was for lumbar back pain.The hcp did not know if the pain was device related.On july 13th, 2018, additional information was received from a manufacturer employee.It was reported that the patient could not have an mri because of her interstim.On july 24th, additional information as received from the hcp.The hcp reported that the patient had not had lumbar back pain for 3-4 years.The hcp stated that the ¿battery is out¿ was referring to the implantable neurostimulation (ins).The hcp further clarified and stated that the battery is not out, it was turned off.The hcp reported that the patient had another bladder surgery.The hcp noted that the patient did not have a handheld programmer.No further complications were anticipated/reported.

Manufacturer Narrative

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

Manufacturer Narrative

This event was incorrectly reported for serious injury.This event is not reportable.Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM II
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7756773
• MDR Text Key: 116235126
• Report Number: 3004209178-2018-17540
• Device Sequence Number: 0
• Product Code: EZW
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 07/13/2018; 08/08/2018
• Supplement Dates FDA Received: 08/09/2018; 10/03/2018
• Date Device Manufactured: 09/08/2017
• 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
• Patient Outcome(s): Required Intervention