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

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Shipping Damage or Problem (1570)

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The healthcare professional (hcp) reported that during implantation the physician connected the new implantable neurostimulator (ins) to the tined lead, the impedance measurement showed only question marks.It was the same after reconnections.The hcp replaced the ins and all impedances were okay.The ins that was not implanted.The patient was fine.The cause was not known.Diagnostics included reconnecting the lead several time and taking several measurements.Interventions included a new ins.The issue was resolved at the time of report.

Manufacturer Narrative

If follow-up, what type?.Correction: upon return of the ins, it was discovered that the serial number was different than what was reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the device found that the implantable neurostimulator (ins) setscrew was backed out too far.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: 8159727
• MDR Text Key: 130410642
• Report Number: 3004209178-2018-27542
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2019

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: 10/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/23/2019; 03/05/2019
• Supplement Dates FDA Received: 02/04/2019; 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1