MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2018

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 consumer regarding a patient who was implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that they patient brought their programmer (pp) with them to a colonoscopy on (b)(6) 2018 to turn stimulation off, but they could not get it to work.It was noted that they got poor communication.They had also tried changing the batteries, removing, replacing, and repositioning the antenna.Further troubleshooting included trying to sync without the antenna, but the issue was not resolved.The patient was sent a replacement pp.It was noted that if the issue remained unresolved with the new pp, the patient would need to work with their healthcare provider to resolve the issue.Additional information was received from a consumer on (b)(6) 2018 indicating that the replacement of the programmer did not resolve the poor communication.The patient reported that it was determined by their urologist that the battery needed to be replaced, and it was replaced on (b)(6) 2018.No further complications were reported.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7587768
• MDR Text Key: 110642325
• Report Number: 3004209178-2018-13104
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2018

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: 04/28/2010
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/11/2018
• Date Device Manufactured: 11/05/2008
• 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
• Patient Age: 56 YR