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

Model Number 3058

Device Problem Malposition of Device (2616)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/28/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3889-28, lot# va171rv, implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient implanted with a neurostimulator for urinary dysfunction and gastrointestinal/pelvic floor.It was reported that the patient¿s previous implantable neurostimulator (ins) had never helped with her bladder symptoms and she had no therapeutic benefit.Her healthcare provider took an x-ray that showed the lead wire was in the wrong spot along the sacral nerve, so it wasn't stimulating the right spot along the nerve.The x-rays were completed in (b)(6) 2016.The patient confirmed she had felt stimulation in the bicycle seat area.Her healthcare provider had tried eight different programs, but they didn't resolve the issue.She met with her healthcare provider and her device was removed and replaced.

Manufacturer Narrative

References the main component of the system and other applicable components are: product id 3889-28, lot# va171rv, implanted: (b)(6) 2016, explanted: (b)(6) 2016,product type lead.

Event Description

Additional information was received from the patient and it was reported that she had no idea what led to the lead wire being in the wrong spot.The patient reported that the lead wire was never in the right place and never worked from the beginning.The patient reported that the only stimulation she ever felt was in the vaginal area.The patient reported that she tried all 12 programs on the neurostimulator (ins) and got the same result ¿ no relief of symptoms.The patient reported that she feared the same problem was occurring now.The patient reported that she had already tried 5 different programs and none of them have worked.The patient reported that she was about to try the sixth program for 2 weeks.The patient reported that she was very close to requesting another x-ray and perhaps having the device removed permanently.

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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6214424
• MDR Text Key: 63606972
• Report Number: 3004209178-2016-27455
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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,Followup
• Report Date: 02/13/2017

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: 11/14/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided; 02/09/2017
• Supplement Dates FDA Received: 02/13/2017; 09/28/2017
• Date Device Manufactured: 05/26/2016
• 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: 70 YR