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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Unable to Obtain Readings (1516)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 06/28/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3889-28, lot# va0r4uq, implanted: (b)(6) 2015, 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 consumer via manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported the patient was at the hospital for a revision of their system when the rep ran an impedance check in pre-op and found all impedances to be out of range and greater than 4,000 ohms.The battery read "???" on programs 1-3, read 93.1 on program 4 and they ran a battery check three times with all results returned as "???".The patient did not feel stimulation at any amplitude and had a return of symptoms.The lead and implantable neurostimulator (ins) were replaced and the issue was resolved at the time of the report.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Analysis of the neurostimulator found no significant anomalies.The setscrew backed out too far but was able to be re-inserted and tightened to a lead without difficulty.Analysis of the lead found lead body conductors broken at or near tines.All circuits were open and no shorts between circuits.All four conductors were broken 5.1 centimeters from the distal end.All four conductors were broken 4.4 centimeters from the distal end.Some of the conductors were crushed; however, there were indicators that the conductors may have been broken before they were crushed.There were suspected tool marks in the outer insulation and the conductors were crushed just proximal to the two most proximal tines.The proximal marker band was moved in order to see the broken conductors.The proximal marker band was moved out of its original location.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.

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: 5805385
• MDR Text Key: 49895738
• Report Number: 3004209178-2016-14484
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/25/2016

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: 08/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 08/25/2016
• Supplement Dates FDA Received: 07/19/2016; 08/26/2016; 08/26/2016; 09/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2015
• 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: 41 YR