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); Unintended Collision (1429)

Patient Problems Renal Disease, End Stage (2039); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119)

Event Date 12/01/2014

Event Type  Injury  

Event Description

Additional information received later was noted that patient was getting 50% or greater symptom reduction.The cause of the event was not determined and was noted as not device related.Reprogramming was needed.It was reported as ¿patient had gastrointestinal issues affect implant.¿ it was reported as unknown if patient experienced loss of therapeutic effect or loss of stimulation.The patient outcome was reported as recovered without permanent impairment.

Event Description

It was reported that the patient was hospitalized 4 days ago for nausea, vomiting, abdominal pain, and renal insufficiency.It was noted that the patient had a fall 4 days ago and that their implantable neurostimulator (ins) felt like the stimulation stopped working a couple of days ago even though it showed the device was on.The patient also stated that they used to feel the stimulation but lost that sensation a couple of days ago.The patient had to be catheterized as they were retaining urine.Using the programmer, it was determined that the stimulation was on and at 1.3 volts which was the typical setting the patient used.There were no further details, interventions or an outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot# va0l9m9, implanted: (b)(6) 2014, product type: lead.Product id: neu_un known_prog, serial# unknown, product type: programmer, physician.(b)(4).

• 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 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: 4376250
• MDR Text Key: 5313615
• Report Number: 3004209178-2014-24769
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

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: 01/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2015
• Date Device Manufactured: 08/04/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 00026 YR