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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 05/04/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id 3889 ,lot# unknown, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead; product id: 3889-28, serial# unknown, product: type lead.Other relevant device(s) are: product id: 3889, serial/lot #: unknown; product id: 3889-28, serial/lot #: unknown, (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that the tined lead was not working and was explanted.It was reported that the patient was in for a battery replacement.Upon the procedure the lead was not working properly and was removed.Another lead was implanted prior and a partial explant was completed.Contributing factors to the reported event were unknown.A proper lead and ins were implanted.It was reported the improper working tined lead and another partial lead were removed.It was reported the issue was resolved at the time of the report.It was further reported that the tined lead that wasn't working properly was removed and replaced with a proper working lead.Another lead was also in the patient and hadn't been removed.The healthcare provider attempted to remove the additional lead and was able to explant most of the lead.No patient symptoms were reported.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.Manufacturer representative reported it was unknown which lead had which issue (one of the interstim tuned leads that was either fully or partially implanted was serial number (b)(4) and the other (b)(4)).It was reported that the lead that was not working properly was tested during the procedure and did not provide stimulation.No further complications reported/anticipated.

Manufacturer Narrative

Device received, analysis not yet complete if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (b(4) and the 2 leads were completed.It was revealed that the ins passed functional testing, one of the leads was segmented, and one of the lead was stretched in the body.Electrical testing determined that continuity was complete on the lead and there no electrical shorts between circuits.Good impedance and stable outputs were observed on all electrode pairs.It was observed that the #0 connector of one of the leads was crushed and the distal end was not return.Also, it was observed that the markings were on the outer insulation of the one of the leads, which was consistent with markings from the use of a tool.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.

Event Description

Additional information received from a manufacturer representative (rep).It was reported that the cause of the lead not working was unknown.Also, the healthcare professional (hcp) was unable to retrieve the remaining lead and there was no cause for why that remained in the patient.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7490493
• MDR Text Key: 107469388
• Report Number: 3004209178-2018-10211
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

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: 03/14/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 05/07/2018; 05/14/2018; 06/22/2018; 07/09/2018; 08/08/2018
• Supplement Dates FDA Received: 05/10/2018; 05/15/2018; 06/27/2018; 07/11/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• 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: 70 YR