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

Model Number 3058

Device Problems Break (1069); Unable to Obtain Readings (1516)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: v742618, implanted: 2011.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 03-jun-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported by a manufacturer representative (rep) that they were in a revision case to replace a lead and they were using the existing ins.The rep reported they were getting ??? marks for values on some case pairs.The rep noted they were with the health care physician (hcp) to do further troubleshooting.While on the call, when impedances were run at 2v c 2 c3 they were ???.When run at 2.5v 450 us c0 c3 were ???.Technical services had the rep run impedances again with parameters of 3v and 90 us.While impedances were being run the caller stated that there may have been some damage to the battery and the rep was indicating that was why they thought they may have been getting some ??? values.Technical services did not have a chance to ask questions regarding how the rep thought the ins would have been damaged.The rep indicated that after rerunning impedances all values were in the normal range.Troubleshooting resolved the reported issue.There were no symptoms reported and as the rep was in a case they couldn¿t provide any further information about the case.In a further clarifying email, the rep stated again the reason for the revision was for a damaged lead.Additional information was received from the rep on 2019-aug-07.In response to the request for clarification of the rep¿s statement of the ¿ins may be damaged¿ and if the ins had been damaged, the rep reported that it was not damaged.In response to the inquiry for cause of the ??? impedance reading the rep stated ¿not sure,¿ stating ¿parameters needed adjusted.¿ in response to the inquiry for the current status of the damaged lead and ins the rep replied that the device (the ins) passed impedance and was implanted.The rep stated they did not know the date on which the event occurred where the lead had been damaged.The rep noted that all of this information had been confirmed with the health care physician (hcp) account.There were no further complications reported.

Manufacturer Narrative

Product id: 3889-28, lot# v742618, implanted: (b)(6) 2011, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep).The manufacturer representative (rep) reported the lead was discarded and that the impedance check was conducted after a new lead was placed.There were no further complications reported/anticipated.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8872486
• MDR Text Key: 153959350
• Report Number: 3004209178-2019-15199
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2019
• Date Device Manufactured: 09/01/2017
• 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