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

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3889-28, lot# va0kk2l, implanted: (b)(6) 2014, explanted: (b)(6) 2016, product type: lead.(b)(4).

Event Description

The manufacturers' representative (rep) reported that they were in the operating room and impedance measurements were taken.The initial impedance tested at 1v/ 210pw and all unipolar pairs showed ??? while bipolar pairs were within normal limits.Additional information from the rep reported that there was a loss of efficacy.Impedances measured prior to the procedure came back normal.The stimulator was checked for remaining longevity, the clinician programmer reported the capacity as ok with 43.5 months.Once the lead was replaced, the impedance came back with c<(>&<)>0- ???, c<(>&<)>2- ???, c<(>&<)>3- ???.All the other configurations were within acceptable range.The setscrew did not feel right when the physician tried to disconnect the original lead and it did not feel right when he tried to connect the stimulator to the new lead either.It was unknown what led to the event.The physician mentioned a major growth spurt of the pediatric patient as a possible cause of the loss of the efficacy.The entire implant was removed and replaced.It remains unknown if the issue resolved.The patient was indicated for gastrointestinal/ pelvic floor.No further information was provided about this event.There was no follow up required.

Manufacturer Narrative

Analysis of ins (serial # (b)(4)) found that the setscrew was backed out too far.Analysis of the lead (lot # va0kk2l) found that the conductor was crushed.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5504931
• MDR Text Key: 40501812
• Report Number: 3004209178-2016-04711
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

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: 04/28/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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: 11 YR