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

Model Number 3058

Device Problems High impedance (1291); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Urinary Frequency (2275); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Event Description

The healthcare provider (hcp) reported a non-functioning device, with possible performance issue, was explanted along with the lead.Intra-operatively, during explantation, the lead broke and only a portion was removed.No information as to why device was non-functioning was provided.No patient injury noted.The patient's indication for use was urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.No outcome was provided with this event.Further follow up was conducted to obtain this information.If new information is received, a supplemental report will be submitted.

Manufacturer Narrative

Analysis of the ins ((b)(4)) determined it to be functionally okay with insignificant anomalies.

Event Description

Additional information received from the healthcare provider (hcp) in response to follow-up reported that the patient first started experiencing the device not functioning around (b)(6) 2015.They experienced increased nocturia and a new onset of pain into the thighs.Abnormal impedances were found on (b)(6) 2015.An x-ray revealed distal lead migration.The cause had not been determined.The patient required an mri of l5 and requested explant of the device.The electrode snapped during explant and a remnant of the electrode was left in place.Impedance for the 0/3 electrode pair was greater than 4000 ohms.A radiographic examination of the sacrum was noted to have no evidence for fracture.The tip of the wire was shown to project anterior to the left mid sacrum.

Manufacturer Narrative

Event date has been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient stating that they never had therapeutic benefit that they were supposed to from the implant and had it explanted.The patient also reported a side effect, they were unable to have an orgasm since implant and since explant of the device.No further complications were reported.

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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5419842
• MDR Text Key: 37789409
• Report Number: 3004209178-2016-01786
• 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,health professional
• Reporter Occupation: Physician
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/17/2017

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: 09/28/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided; 08/14/2017; 08/14/2017
• Supplement Dates FDA Received: 03/24/2016; 08/17/2017; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2014
• 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
• Patient Age: 74 YR