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

Model Number 3058

Device Problem Unable to Obtain Readings (1516)

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

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3037, serial# (b)(4), product type: programmer, patient; product id 3 889-28, lot# va0wze9, implanted: (b)(6) 2015, product type: lead.(b)(4).Analysis of the ipg (s/n (b)(4)) found no significant anomaly, normal impedances were measured on all electrode pair combinations.

Event Description

It was reported that the surgeon replaced the lead and left the old implantable neurostimulator (ins) in the pocket.They then tested impedances with the old ins and the new lead and found that all of the case values were '???' which was tested at 2v and 3v.The rep then noted that they replaced the ins and plugged the new ins into the new lead.When they ran impedances, all values were >4000ohms.It was most likely a connection issue and the rep had the surgeon pull out the lead, wipe down, and reinsert.This resolved the impedance issue.It was unknown whether the ins was out of the pocket when the impedance testing was done as >4000ohms is to be expected when the ins is out of the pocket.This was when the old ins was being tested with the new lead.It was later confirmed that impedance testing was done with the ins in the pocket.The initial sutures had been placed and it was taken out to check to make sure the lead was all the way in, and the ins was replaced back into the pocket completely and the impedances were run again.The lead was replaced due to decreased symptom control.The patient stated that it worked initially but the therapy benefit decreased despite reprogramming.She had an uncomfortable sensation near her vagina.The physician recommended replacement after last attempted reprogramming.These reported adverse events are unknown to be resolved at this time.

Manufacturer Narrative

(b)(4).

Event Description

Additional information from the health care professional reported that the decreased symptom control and uncomfortable sensation in the pelvic floor was resolved.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 5005232
• MDR Text Key: 23090031
• Report Number: 3004209178-2015-16096
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/22/2015

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: 04/28/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2013
• 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: 00071 YR