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); High impedance (1291); Unable to Obtain Readings (1516)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported that all impedances were greater than 4,000 ohms except for the electrode two unipolar pair.Increasing the test voltage and pulse width did not resolve the issue.The patient was not getting relief, even at 7.5 v.They had no response and did not feel anything.¿???¿ was seen during longevity tests.It was reported that bipolar pair zero and two did not have high impedances.The patient felt stimulation and had therapeutic effect with that pair.The patient was scheduled for a follow-up appointment in four weeks.

Manufacturer Narrative

Concomitant product: product id 3037, serial # (b)(4), product type programmer, patient; product id 3 889-28, lot # va0jqyb, implanted: (b)(6) 2014, product type lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the lead was replaced and everything was fine; the patient was feeling the stimulation just fine.The "broken" lead was explanted whole, and was to be sent to analysis.

Event Description

It was reported that the leads were going to be replaced.Therapy worked for a little while but was not effective long term.

• 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: 4679915
• MDR Text Key: 17294994
• Report Number: 3004209178-2015-07018
• 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,Followup
• Report Date: 03/27/2015

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: 02/14/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 04/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/18/2015; 06/12/2015
• Date Device Manufactured: 08/21/2012
• 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: 00038 YR