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

Model Number 3058

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

Patient Problems Incontinence (1928); Therapeutic Response, Decreased (2271)

Event Date 12/09/2011

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3037, serial# (b)(4), product type: programmer, patient.Product id: 3 889-28, lot# v868869, implanted: (b)(6) 2011, product type: lead.(b)(4).

Event Description

The manufacturers¿ representative (rep) reported that impedance measurements were taken.At the default setting, 1v/210pw: all contacts showed >4000 except contact c0 which showed approximately 1051 ohms.The device was re-tested at default setting and all contacts showed >4000 ohms.The setting was increased to 3v/300pw: some showed ??? and some showed >4000 ohms.The breakdown of those readings was not known.The device was re-tested at 3v/300pw and all contacts showed >4000 ohms.The patient felt stimulation in the groin area after each electrode impedance testing.The implantable neurostimulator battery showed okay.The patient was programmer at c+1-2 4.3v.The rep stated it was his first time seeing the patient; there were no old records on hand.It was noted that a fall could be related to the issue.The patient was not in good health, he fell and hit his head and it was unknown if the implantable neurostimulator was hit.There was a return of symptoms and leakage.Additional information from the rep noted the device was shut off; the health care professional put the patient on mybetrix and planned to see him a month after.They planned to discuss leaving the device in and having it off and taking the entire device out for lead replacement and therapy restoration.The patient was indicated for urinary dysfunction/ sacral nerve stim and gastrointestinal/ pelvic floor.No further information was provided about this event.If additional information is received, a follow up report will be sent.

• 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: 5069130
• MDR Text Key: 27072265
• Report Number: 3004209178-2015-17769
• 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
• Report Date: 08/14/2015

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: 04/28/2013
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Date Device Manufactured: 11/07/2011
• 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 Age: 00077 YR