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

Model Number 3058

Device Problems High impedance (1291); Unable to Obtain Readings (1516); Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported the patient was having the full implant implanted about a month prior.The tined lead was positioned during the procedure, but gave poor response on 2 electrodes (0 and 1) so it was repositioned.Three electrodes (1, 2, and 3) then captured motor responses.Impedances were tested in theatre after closure and electrodes 1, 2, and 3 showed an open circuit.Impedances were high and measured to be greater than 4 ,000 ohms.The impedances were measured again six hours later with the same result.Electrode pair c and 0 also showed ¿???.¿ there were no sensory responses on the open circuit electrode at high stimulation levels.It was noted that a peri-anal sensation using electrode 0 in unipolar was achieved.The patient was set with 4 programs with various frequencies, and the sensation was reportedly ¿sharp¿ per the representative¿s standard.Following the implant, the patient had some voiding function, but stimulation was not optimal.Stimulation was uncomfortable and less effective than the basic evaluation.It was noted that a surgical revision was being considered if suboptimal response occurred.It was further stated that there may be an explant if intraoperative testing was inconclusive.No further information was reported.Further follow up is being conducted to obtain additional information.A follow up report will be sent if additional information is received.

Manufacturer Narrative

Implant dates are approximations.Concomitant medical products: product id: 309328, lot# 0208365849, implanted: (b)(6) 2014, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was later reported that the patient had surgery on (b)(6) 2015.It was stated that the impedance issues were due to misalignment.Therefore, the device was not removed, but adjusted.When the device was put back together all of the impedances were still not good, but the patient got motor responses.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the patient was to have a revision on (b)(6) 2015.The patient had been reviewed twice and the same problems of impedance and no sensory on other electrodes were noted.It was stated the patient was at their pre-implant state experiencing retention.The limited stimulation option (unipolar electrode 0) only elicited the desire to void, but there was no voiding.The stimulation also induced pain in the pelvic floor.A second follow up report will be sent if additional information is received.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4488351
• MDR Text Key: 5568064
• Report Number: 3004209178-2015-01864
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2015

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: 12/28/2015
• 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: 03/19/2015
• Initial Date FDA Received: 02/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/02/2015; 03/24/2015
• Date Device Manufactured: 07/07/2014
• 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