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

Model Number 3058

Device Problems Connection Problem (2900); Human-Device Interface Problem (2949); Impedance Problem (2950)

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

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that healthcare provider (hcp) went to insert the lead into the battery and the lead wouldn't go in, there was lead insertion difficulty during implant.The hcp backed out the screw further, that didn't work, so they then used something like suture wire to see if that would insert and that didn't go either.The hcp backed out the screw further, then the lead went all the way in.The hcp completely screwed it on, heard the click, and placed it in the pocket.It was reported that they impedances were out of range, so the hcp took the battery from the pocket and it slid off the lead.The hcp did not want to use that ins, so another one was opened and used with no problems.It was noted that the caller was calling after the case to report it.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) ((b)(4)) revealed no significant anomaly, the ins was functionally okay.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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
• MDR Report Key: 7625008
• MDR Text Key: 111894489
• Report Number: 3004209178-2018-13972
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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,health
• Type of Report: Initial,Followup,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 06/21/2018; 07/09/2018; 07/24/2018; 08/08/2018
• Supplement Dates FDA Received: 06/25/2018; 07/10/2018; 08/14/2018; 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR