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 Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported that the representative was in a revision case and the first time impedances were read, he saw ??? on c,1 and c,2.Caller was recommended re-running them at 2 volts and 360 pw (pulse width) and he did and the impedances were then normal.They were using the same battery from 2010.Caller states under the battery life it said okay, 109! and *new neurostimulator.Technical services explained that occurs after a por (power on reset) and spoke about changing out the ins (stimulator).Additional information received reports the reason for lead revision was because healthcare provider and the patient decide it was right thing to do.Healthcare provider noticed some impedance issues with his clinician programmer asked that the representative confirm the impedance and the representative did on monday (b)(6).The patient was not getting the therapeutic results that she had in the past.They also noticed that the ipg (stimulator) needed to be replaced and confirmed with technical services.The representative was notified that the patient would be scheduled for a lead revision and possible ipg replacement on monday (b)(6).I was not told of any date of a problem.It was later reported that the patient was doing fine now.

Manufacturer Narrative

Concomitant products: product id: 3037, serial# (b)(4), product type: programmer, patient.Product id: 3093-28, lot# j0424905v, implanted: (b)(6) 2004, explanted: (b)(6) 2015, product type: lead.Product id: 3095-10, serial# (b)(4), implanted: (b)(6) 2004, explanted: (b)(6) 2010, product type: extension.Product id: 3093-28, lot# j0424905v, implanted: (b)(6) 2004, explanted: (b)(6) 2015, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

• 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: 4788459
• MDR Text Key: 5802665
• Report Number: 3004209178-2015-09529
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

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: 05/28/2011
• 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: 06/24/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2015
• Date Device Manufactured: 12/02/2009
• 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: 00055 YR