MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot# va0vrbb, implanted: (b)(6) 2015, product type: lead.Product id: 3037, serial# (b)(4), product type: programmer, patient.(b)(4).Analysis of stimulator (b)(4) reveals no anomaly found.

Event Description

It was reported that the representative was getting question marks (???) in results for impendence.The representative intraoperative with stage 2 implant and getting "??" with all case pairs.Both ins (stimulator) and lead were brand new.Caller had only once seen a numerical value with a case pair (c/0) but can't remember what the number was exactly.Bipolar pairs had been normal range.Ins in pocket.Had caller run impendence at 2 volts, 390us, but all unipolar were ?? and bipolar were 01=1328, 02=1328, 03=1342, 12=1328, 13=1328, 23=1328.Tried conducting impendence at 2volts, 360us but this didn't resolve issue.They had turned off light already and there was no fluoro present or being used.There was other monitoring equipment on and being used since patient was under general anesthesia.The battery was replaced with a new ins and the impedance was perfect the very first time.It was later reported that the patient was under anesthesia and therefore unaware of any issues with device.Additional information received reports during implant the impendence tests gave ??? for all "c" configuration.After calling technical support a new ins was used and gave perfect impendence reading.There was no patient death and no patient injury.

• 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: 4931730
• MDR Text Key: 24597422
• Report Number: 3004209178-2015-13834
• 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: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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: 00076 YR