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); Device Contamination with Chemical or Other Material (2944)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Main component of the system and other applicable components are: product id 3889-28, lot # va0qyy5, product type lead.Analysis of the implantable neurostimulator (s/n (b)(4)) showed that the device was functionally okay with insignificant anomalies.

Event Description

The manufacturers¿ representative (rep) reported that there was a change in therapy; the cause was unknown and it occurred about a year prior to report.They were doing a lead revision on (b)(6) 2016 as the patient had a lack of efficacy.X-rays were done and the lead looked intact.They were able to obtain motor response at an appropriate level.Impedance check was carried out at 1.5v, everything was normal except for ??? on c-0 and c-3.They increased it to 2.0v and all impedances were in normal range.It was noted that the patient was reprogrammed several times in the past.It was unknown if the patient completely recovered.During the revision, the implantable neurostimulator (ins) was removed and they noticed blood in the header block where electrode 3 was.The physician did not attempt to get the blood out as it was very deep in the header block.The ins was replaced and returned.Per device manufacturers¿ registry, the lead was also replaced.The patient was indicated for gastrointestinal/ pelvic floor.No further information was provided about this event.

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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5671369
• MDR Text Key: 45670255
• Report Number: 3004209178-2016-10059
• Device Sequence Number: 1
• Product Code: EZW
• 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,Followup
• Report Date: 05/20/2016

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: 06/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: 04/25/2016
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• 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