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 Code Available (3191)

Event Date 06/25/2015

Event Type  Injury  

Event Description

It was reported that the manufacturer representative kept getting ??? in the results for impedances.They were testing at 2v and 210 pulse width and some cases pairs were still ???, but all bipolar pairs came back with 1700 to 1900 ohms.The manufacturer representative tested the lead and received motor responses at 7v to 8v.The patient experienced no symptoms.It was determined that there was a possible lead defect and a different lead was implanted.The unused lead was being sent in for analysis.

Event Description

Additional information received reported that there was lead breakage and the lead was not implanted as it was defective.The device was not used in the patient.There was no patient death.

Manufacturer Narrative

Additional device code (b)(4).Analysis of the tined lead (va0vapd) found that the lead was good electrically.The conductor coils were crushed 7.8 cm from the distal end of the lead.Impedances were measured and all impedances were less than 1000 ohms.Conclusion codes have been updated.

Manufacturer Narrative

Concomitant medical products: product id 3889-28, lot# va0vapd, product type: lead.Product id 3037, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

Additional information from representative reports the patient experienced no symptoms, she was under anesthesia when impedance check was being done.The representative do not believe a cause for the impedance was determined.Different troubleshooting was performed as instructed by technical services and then it was recommended by technical services that a different lead be used.

• 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: 4915144
• MDR Text Key: 6032126
• Report Number: 3004209178-2015-13386
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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: 10/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 07/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 00053 YR